FDA Calendar

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Our top table displays upcoming, expected FDA events while the second table documents previous FDA events.

-	Company	Ticker	Drug	Indication	Event Type	Priority Review
12-23-22	Coherus BioSciences	CHRS	toripalimab	In combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy	BLA	No
9-7-23	Merck	MRK	letermovir	Use of letermovir for 200 days in adults receiving an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection	sNDA	No
10-8-23	Alnylam Pharmaceuticals	ALNY	patisiran	Treatment of cardiomyopathy of transthyretin-mediated amyloidosis	sNDA	No
10-17-23	Ardelyx	ARDX	tenapanor	Control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder	NDA	No
10-21-23	Biomarin Pharmaceuticals	BMRN	vosoritide	Treatment of patients with achondoplasia who are 5 years of age or older	sBLA	No
10-22-23	Regeneron	REGN	dupilumab	Treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria	sBLA	No
10-26-23	Catalyst Pharmaceuticals	CPRX	vamorolone	Treatment of Duchenne Muscular Dystrophy	NDA	No
10-28-23	Pfizer	PFE	MenABCWY	Prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age	BLA	No
11-12-23	AstraZeneca	AZN	capivasertib	Treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen	NDA	Yes
11-17-23	Phathom Pharmaceuticals	PHAT	vonoprazan	Treatment of Erosive GERD	NDA	No
11-30-23	Valneva	VALN	VLA1553	Chikungunya vaccine	BLA	Yes
12-8-23	CRISPR Therapeutics	CRSP	exa-cel	Treatment of severe sickle cell disease	BLA	Yes
12-20-23	bluebird bio	BLUE	lovo-cel	Gene therapy for patients 12 years or older with sickle cell disease who have a history of vaso-occlusive events	BLA	Yes
12-22-23	Ionis Pharmaceuticals	IONS	eplontersen	Treatment of patients with hereditary transthyretin-mediated amyloid polyneuropathy	NDA	No
12-23-23	Pfizer	PFE	enzalutamide	Treatment of patients with non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrance	sNDA	Yes
1-3-24	Checkpoint Therapeutics	CKPT	cosibelimab	Treatment for patients with metastatic cutaneous squamous cell carcinoma (“cSCC”) or locally advanced cSCC who are not candidates for curative surgery or radiation	BLA	No
1-31-24	Regeneron	REGN	dupilumab	Treatment of children aged 1 to 11 years with eosinophilic esophagitis (EoE)	sBLA	Yes
2-24-24	Iovance Biotherapeutics	IOVA	lifileucel	Treatment of patients with advanced melanoma	BLA	Yes
3-14-24	Madrigal Pharmaceuticals	MDGL	resmetirom	Treatment of adult patients with NASH with liver fibrosis	NDA	Yes
3-18-24	Orchard Therapeutics	ORTX	OTL-200	Treatment of metachromatic leukodystrophy (MLD)	BLA	Yes
3-26-24	Merck	MRK	sotatercept	Treatment of adult patients with pulmonary arterial hypertension (PAH)	BLA	Yes
3-30-24	CRISPR Therapeutics	CRSP	exa-cel	Treatment of patients with transfusion-dependent beta thalassemia	BLA	No
3-31-24	Regeneron	REGN	odronextamab	Treatment of adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies	BLA	Yes
3-31-24	Rocket Pharmaceuticals	RCKT	marnetegragene autotemcel	Gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I)	BLA	Yes

Recent FDA Activity

Date	Action	Event Date	Company	Ticker	Drug	Indication
10-02-23	PDUFA Date Added	3-31-24	Rocket Pharmaceuticals	RCKT	marnetegragene autotemcel	Gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I)
09-29-23	PDUFA Date Added	3-31-24	Regeneron	REGN	odronextamab	Treatment of adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies
09-28-23	PDUFA Date Added	3-26-24	Merck	MRK	sotatercept	Treatment of adult patients with pulmonary arterial hypertension (PAH)
09-28-23	Approval Announced	10-29-22	Amicus Therapeuticss	FOLD	miglustat	Treatment of Pompe Disease
09-28-23	Approval Announced	10-29-22	Amicus Therapeuticss	FOLD	cipaglucosidase	Treatment of Pompe Disease
09-22-23	Approval Announced	7-20-23	Eli Lilly	LLY	empagliflozin	Treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD)
09-20-23	CRL Issued	9-19-23	ARS Pharmaceuticals	SPRY	epinephrine nasal spray	Treatment of allergic reactions including anaphylaxis
09-18-23	PDUFA Date Added	3-18-24	Orchard Therapeutics	ORTX	OTL-200	Treatment of metachromatic leukodystrophy (MLD)
09-15-23	Approval Announced	9-16-23	GSK	GSK	momelotinib	Treatment of patients with myelofibrosis and anemia
09-13-23	PDUFA Date Added	3-14-23	Madrigal Pharmaceuticals	MDGL	resmetirom	Treatment of adult patients with NASH with liver fibrosis
09-11-23	Approval Announced	9-9-23	BioLineRx	BLRX	motixafortide	Stem cell mobilization for autologous transplantation in multiple myeloma patients
08-30-23	CRL Issued	8-29-23	Outlook Therapeutics	OLTK	ONS-5010	Treatment of wet age-related macular degeneration (wet AMD)
08-28-23	Approval Announced	8-28-23	Bristol-Myers Sqibb	BMY	luspatercept	Treatment of anemia without previous use of erythropoiesis-stimulating agents in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions.
08-23-23	PDUFA Date Added	12-23-23	Pfizer	PFE	enzalutamide	Treatment of patients with non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrance
08-21-23	Approval Announced	8-21-23	Pfizer	PFE	RSVpreF	Prevention of medically attended lower respiratory tract illness and severe medically attended lower respiratory tract infections caused by RSV in infants from birth up to six months of age
08-18-23	Approval Announced	8-20-23	Regeneron Pharmaceuticals	REGN	pozelimab	Treatment for adults and children as young as 1 year of age with CHAPLE disease
08-18-23	Approval Announced	8-20-23	Neurocrine Biosciences	NBIX	valbenazine	Treatment for chorea associated with Huntington disease (HD)
08-15-23	Approval Announced	8-14-23	Delcath System	DCTH	HEPZATO	Treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM)
08-14-23	Approval Announced	8-19-23	Revance Therapeutics	RVNC	DaxibotulinumtoxinA	Treatment of cervical dystonia in adults
08-09-23	CRL Issued	8-9-23	Galera Therapeutics	GRTX	avasopasem	Reduction of radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC)
08-05-23	Approval Announced	8-19-23	Iveric bio	ISEE	avacincaptad pegol	Treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD)
08-04-23	Mixed Approval	8-5-23	Sage Therapeutics	SAGE	zuranolone	Treatment of major depressive disorder (MDD) and postpartum depression (PPD
07-31-23	CRL Issued	7-28-23	Citius Pharmaceuticals	CTXR	Denileukin diftitox	Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL)
07-21-23	Approval Announced	7-23-23	Verrica Pharmaceuticals	VRCA	VP-102	Treatment of molluscum contagiosum (“molluscum”)
07-06-23	Approval Announced	7-6-23	Biogen	BIIB	lecanemab	Treatment of Alzheimer's DIsease
07-03-23	CRL Issued	6-30-23	Amneal Pharmaceuticals	AMRX	IPX203	Treatment of Parkinson’s disease (PD)
06-29-23	Approval Announced	6-30-23	Biomarin Pharmaceuticals	BMRN	valoctogene roxaparvovec	Gene therapy for adults with severe hemophilia A
06-27-23	CRL Issued	6-27-23	Regeneron Pharmaceuticals	REGN	aflibercept	Treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy
06-22-23	Approval Announced	6-22-23	Sarepta Therapeutics	SRPT	SRP-9001	Treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene
06-22-23	CRL Issued	6-22-23	Intercept Pharmaceuticals	ICPT	obeticholic acid	Treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH)
06-16-23	Approval Announced	6-16-23	Bristol-Myers Squib	BMY	mavacamten	To reduce the need for septal reduction therapy (SRT) in patients with obstructive cardiomyopathy
06-12-23	Approval Announced	6-14-23	Ironwood Therapeutics	IRWD	linaclotide	Treatment of functional constipation in pediatric patients aged 6 to 17
05-26-23	PDUFA Date Added	11-25-23	Iovance Biotherapeutics	IOVA	lifileucel	Treatment of patients with advanced melanoma
05-26-23	Approval Announced	5-27-23	Lexicon Pharmaceuticals	LXRX	sotagliflozin	Treatment of heart failure
05-22-23	Approval Announced	5-22-23	Blueprint Medicines	BPMC	avapritinib	Treatment of adult with indolent systemic mastocytosis
05-19-23	Approval Announced	5-21-23	Abbvie	ABBV	epcoritamab	Treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
05-19-23	Approval Announced	5-19-23	Krystal Biotech	KRYS	B-VEC	Treatment of patients with dystrophic epidermolysis bullosa (DEB)
05-17-23	PDUFA Date Added	8-17-23	Ardelyx	ARDX	tenapanor	Control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder
05-11-23	CRL Issued	5-23-23	ImmunityBio	IBRX	N-803	Treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ
05-10-23	Approval Announced	5-9-23	Protalix BioTherapeutics	PLX	pegunigalsidase alfa	Treatment of adult patients with Fabry disease
05-08-23	Approval Announced	5-8-23	Eyenovia	EYEN	MydCombi	In-office pupil dilation
05-04-23	Approval Announced	5-3-23	Vertex Pharmaceuticals	VRTX	Kalydeco	Treatment of cystic fibrosis for patients aged 1 month to < 4 months of age
05-01-23	CRL Issued	4-30-23	Ascendis Pharma	ASND	palopegteriparatide	Treatment of hypoparathyroidism in adults
04-26-23	Approval Announced	4-28-23	Vertex Pharmaceuticals	VRTX	Trikafta	Treatment of cystic fibrosis for patients aged 2 to 5 years of age
04-26-23	Approval Announced	4-26-23	Seres Therapeutics	MCRB	SER-109	Prevention of recurrent C. difficile infection (rCDI)
04-25-23	Approval Announced	4-25-23	Biogen	BIIB	tofersen	Treatment of SOD1 amyotrophic lateral sclerosis (ALS)
04-19-23	Approval Announced	4-2-23	Roche	RHHBY	polatuzumab vedotin	Combination treatment with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated DLBCL
04-17-23	Approval Announced	5-1-23	Gamida Cell	GMDA	omidubicel	Treatment of patients with blood cancers in need of allogenic hematopoietic stem cell transplant
04-03-23	Approval Announced	4-21-23	Seagen	SGEN	enfortumab vedotin	Treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy in combination with pembrolizumab
03-29-23	Approval Announced	3-29-23	Emergent Biosolutions	EBS	naloxone	Treatment for known or suspected opioid overdose
03-28-23	PDUFA Date Added	8-14-23	Delcath System	DCTH	HEPZATO	Treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM)
03-24-23	Approval Announced	3-29-23	Pharming Group	PHAR	leniolisib	Treatment for adolescents and adults with APDS
03-23-23	Approval Announced	3-22-23	Cidara Therapeutic	CDTX	rezafungin	Treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options
03-22-23	Approval Announced	3-30-23	Regeneron Pharmaceuticals	REGN	evinacumab	Adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH)
03-10-23	ADCOM Added	5-19-23	Intercept Pharmaceuticals	ICPT	obeticholic acid	Treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH)
03-10-23	Approval Announced	3-23-23	Biohaven Pharmaceuticals	BHVN	zavegepant	Acute treatment of migraine in adults
03-07-23	PDUFA Date Added	12-22-23	Ionis Pharmaceuticals	IONS	eplontersen	Treatment of patients with hereditary transthyretin-mediated amyloid polyneuropathy
03-07-23	PDUFA Date Added	10-21-23	Biomarin Pharmaceuticals	BMRN	vosoritide	Treatment of patients with achondoplasia who are 5 years of age or older
02-28-23	Approval Announced	2-28-23	Reata Pharmaceuticals	RETA	omaveloxolone	Treatment of patients with Friedreich’s ataxia
02-28-23	CRL Issued	2-28-23	Cytokinetics	CYTK	omecamtiv mecarbil	Treatment of heart failure with reduced ejection fraction
02-27-23	PDUFA Date Added	7-23-23	Verrica Pharmaceuticals	VRCA	VP-102	Treatment of molluscum contagiosum (“molluscum”)
02-21-23	PDUFA Date Added	8-21-23	Pfizer	PFE	RSVpreF	Prevention of medically attended lower respiratory tract illness and severe medically attended lower respiratory tract infections caused by RSV in infants from birth up to six months of age
02-21-23	PDUFA Date Added	10-8-23	Alnylam Pharmaceuticals	ALNY	patisiran	Treatment of cardiomyopathy of transthyretin-mediated amyloidosis
02-17-23	Approval Announced	2-26-23	Apellis Pharmaceuticals	APLS	pegcetacoplan	Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
02-17-23	Approval Announced	2-17-23	Travere Therapeutics	TVTX	sparsentan	Treatment of IgA nephropathy (IgAN)
02-13-23	PDUFA Date Added	9-28-23	Ocuphire Pharma	OCUP	Nyxol	Treatment of pharmacologically-induced mydriasis (RM)
02-08-23	Approval Announced	2-11-23	Regeneron Pharmaceuticals	REGN	aflibercept	Treatment of Retinopathy of Prematurity (ROP) in preterm infants
02-03-23	Approval Announced	2-5-23	Takeda	TAK	lanadelumab	Prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age
01-27-23	Approval Announced	1-29-23	Merck	MRK	pembrolizumab	Adjuvant treatment of patients with stage IB (≥4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection
01-23-23	PDUFA Date Added	5-22-23	Blueprint Medicines	BPMC	avapritinib	Treatment of adult with indolent systemic mastocytosis
01-20-23	PDUFA Date Added	7-20-23	Eli Lilly	LLY	empagliflozin	Treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD)
01-19-23	Approval Announced	1-20-23	BeiGene	BGNE	zanubrutinib	Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
01-19-23	Approval Announced	1-19-23	Seagen	SGEN	tucatinib	Combination with trastuzumab for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease
01-06-23	Approval Announced	1-6-23	Biogen	BIIB	lecanemab	Treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD with confirmed presence of amyloid pathology in the brain
12-30-22	Approval Announced	1-1-23	MediWound	MDWD	NexoBrid	Eschar removal in adults with deep partial thickness and/or full thickness thermal burns
12-28-22	Approval Announced	12-28-22	TG Therapeutics	TGTX	ublituximab	Treatment for patients with relapsing forms of multiple sclerosis (RMS)
12-23-22	Approval Announced	12-29-22	Roche	RHHBY	mosunetuzumab	Treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies
12-22-22	Approval Announced	01-15-23	Acer Therapeutics	ACER	sodium phenylbutyrate	Treatment of patients with Urea Cycle Disorders (UCDs)
12-22-22	PDUFA Date Added	8-20-23	Neurocrine Biosciences	NBIX	valbenazine	Treatment for chorea associated with Huntington disease (HD)
12-21-22	Approval Announced	10-4-22	Roche	RHHBY	tocilizumab	Treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation
12-20-22	PDUFA Date Added	4-21-23	Seagen	SGEN	enfortumab vedotin	Treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy in combination with pembrolizumab
12-12-22	Approval Announced	12-14-22	Mirati Therapeutics	MTRX	adagrasib	Treatment of patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy
12-07-22	PDUFA Date Added	5-7-23	Pfizer	PFE	RSVPreF3	Prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older
12-06-22	PDUFA Date Added	3-29-23	Emergent Biosolutions	EBS	naloxone	Treatment for known or suspected opioid overdose
12-01-22	CRL Issued	11-30-22	Y-mabs Therapeutics	YMAB	omburtamab	Treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma
12-01-22	PDUFA Date Added	9-28-23	Citius Pharmaceuticals	CTXR	Denileukin diftitox	Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL)
11-30-22	PDUFA Date Added	3-30-23	Regeneron Pharmaceuticals	REGN	evinacumab	Adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH)
11-25-22	CRL Issued	11-24-22	Spectrum Pharmaceuticals	SPPI	poziotinib	Treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations
11-22-22	Extension of PDUFA Date	5-1-23	Gamida Cell	GMDA	omidubicel	Treatment of patients with blood cancers in need of allogenic hematopoietic stem cell transplant
11-21-22	PDUFA Date Added	5-21-23	Abbvie	ABBV	epcoritamab	Treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
11-18-22	Extension of PDUFA Date	2-26-23	Apellis Pharmaceuticals	APLS	pegcetacoplan	Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
11-17-22	Approval Announced	11-17-22	Provention Bio	PRVB	teplizumab	For the delay of clinical type 1 diabetes (T1D) in at-risk individuals
11-14-22	Approval Announced	11-28-22	Immunogen	IMGN	mirvetuximab	Treatment of patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments
11-02-22	PDUFA Date Added	5-3-23	GSK	GSK	RSVPreF3	Prevention of respiratory syncytial virus (RSV) in adults
10-31-22	PDUFA Date Added	4-30-23	Ascendis Pharma	ASND	palopegteriparatide	Treatment of hypoparathyroidism in adults
10-26-22	PDUFA Date Added	4-26-23	Seres Therapeutics	MCRB	SER-109	Prevention of recurrent C. difficile infection (rCDI)
10-17-22	Extension of PDUFA Date	4-25-23	Biogen	BIIB	tofersen	Treatment of SOD1 amyotrophic lateral sclerosis (ALS)
10-10-22	Approval Announced	10-8-22	scPharmaceuticals	SCPH	furosemide	Treatment of congestion in patients with worsening heart failure
10-10-22	CRL Issued	10-4-22	Supernus Pharmaceuticals	SUPN	apomorphine	Treatment of motor fluctuations (OFF episodes) in pParkinson's disease
10-06-22	Approval Announced	10-6-22	Alnylam Pharmaceuticals	ALNY	lumasiran	Reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1)
10-05-22	PDUFA Date Added	2-5-23	Takeda	TAK	lanadelumab	Prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age
09-29-22	Approval Announced	09-29-22	Amylyx	AMLX	AMX0035	Treatment of amyotrophic lateral sclerosis (ALS)
09-20-22	Approval Announced	09-23-22	Fennec Pharmaceuticals	FENC	sodium thiosulfate	Prevention of platinum-induced ototoxicity in pediatric patients one month to <18 years of age with localized, non-metastatic, solid tumors
09-19-22	PDUFA Date Added	1-19-23	Seagen	SGEN	tucatinib	Combination with trastuzumab for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease
09-19-22	Approval Announced	09-16-22	bluebird Bio	BLUE	eli-cel	Gene therapy for cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age
09-09-22	Approval Announced	09-09-22	Spectrum Pharmaceuticals	SPPI	eflapegrastim	To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
09-01-22	ADCOM Added	10-28-22	Y-mabs Therapeutics	YMAB	omburtamab	Treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma
08-31-22	Approval Announced	12-23-21	Aquestive Therapeutics	AQST	diazepam	Treatment of seizure clusters
08-19-22	Approval Announced	08-22-21	Axsome Therapeutics	AXSM	dextromethorphan-bupropion	Treatment of major depressive disorder (MDD)
08-17-22	Approval Announced	08-19-22	bluebird Bio	BLUE	betibeglogene autotemcel	Treatment of adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions
08-16-22	PDUFA Date Added	4-2-23	Roche	RHHBY	polatuzumab vedotin	Combination treatment with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated DLBCL
08-05-22	Approval Announced	08-06-22	Pfizer	PFE	relugolix	Management of moderate to severe pain associated with endometriosis
08-05-22	CRL Issued	08-04-22	Acadia Pharmaceuticals	ACAD	pimavanserin	Treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
08-03-22	PDUFA Date Added	1-1-23	MediWound	MDWD	NexoBrid	Eschar removal in adults with deep partial thickness and/or full thickness thermal burns
08-02-22	PDUFA Date Added	3-23-23	Incyte	INCY	ruxolitinib	Once daily formulation of ruxolitinib
08-01-22	PDUFA Date Added	1-30-23	Gamida Cell	GMDA	omidubicel	Treatment of patients with blood cancers in need of allogenic hematopoietic stem cell transplant
07-28-22	PDUFA Date Added	01-15-23	Acer Therapeutics	ACER	sodium phenylbutyrate	Treatment of patients with Urea Cycle Disorders (UCDs)
07-26-22	PDUFA Date Added	1-25-23	Biogen	BIIB	tofersen	Treatment of SOD1 amyotrophic lateral sclerosis (ALS)
07-25-22	PDUFA Date Added	10-25-22	AstraZeneca	AZN	trastuzumab deruxtecan	Treatment of adult patients in the US with unresectable or metastatic HER2-low breast cancer who have received a prior therapy in the metastatic setting
07-19-22	PDUFA Date Added	11-26-22	Apellis Pharmaceuticals	APLS	pegcetacoplan	Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
07-19-22	Approval Announced	07-18-22	Incyte	INCY	ruxolitinib cream	Treatment of vitiligo
07-19-22	Approval Announced	10-15-21	Avadel Pharmaceuticals	AVDL	sodium oxybate	Treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy
07-08-22	Approval Announced	07-07-22	Horizon Therapeutics	HZNP	pegloticase	Treatment of patients with uncontrolled gout in combination with methotrexate
07-06-22	PDUFA Date Added	12-29-22	Roche	RHHBY	mosunetuzumab	Treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies
07-06-22	PDUFA Date Added	12-23-22	Coherus BioSciences	CHRS	toripalimab	In combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy
07-06-22	PDUFA Date Added	1-6-23	Biogen	BIIB	lecanemab	Treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD with confirmed presence of amyloid pathology in the brain
06-29-22	PDUFA Date Added	2-28-23	Regeneron Pharmaceuticals	REGN	aflibercept	Treatment of patients with diabetic retinopathy
06-24-22	PDUFA Date Added	4-24-23	Emergent Biosolutions	EBS	AV7909	Post-exposure prophylaxis of anthrax
06-24-22	ADCOM Added	12-13-22	Cytokinetics	CYTK	omecamtiv mecarbil	Treatment of heart failure with reduced ejection fraction
06-22-22	Approval Announced	07-01-22	Merck	MRK	Pneu-Ped	Prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age
06-17-22	Extension of PDUFA Date	2-28-23	Cytokinetics	CYTK	omecamtiv mecarbil	Treatment of heart failure with reduced ejection fraction
06-16-22	Approval Announced	06-16-22	Rhythm Pharmaceuticals	RYTM	setmelanotide	Treatment of patients with Bardet-Biedl syndrome (BBS) or Alström syndrome
06-13-22	Extension of PDUFA Date	1-20-23	BeiGene	BGNE	zanubrutinib	Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
06-13-22	PDUFA Date Added	1-29-23	Merck	MRK	pembrolizumab	Adjuvant treatment of patients with stage IB (≥4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection
06-07-22	Approval Announced	06-09-22	Regeneron Pharmaceuticals	REGN	dupilumab	Add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
06-03-22	Extension of PDUFA Date	09-29-22	Amylyx	AMLX	AMX0035	Treatment of amyotrophic lateral sclerosis (ALS)
06-02-22	PDUFA Date Added	1-29-23	Pfizer	PFE	Myfembree	Treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women
05-31-22	PDUFA Date Added	9-30-22	Regeneron Pharmaceuticals	REGN	dupilumab	Treatment of adults with prurigo nodularis
05-31-22	Approval Announced	07-25-22	PTC Therapeutics	PTCT	risdiplam	Treatment of pre-symptomatic infants under 2 months old with spinal muscular atrophy (SMA)
05-31-22	Extension of PDUFA Date	12-28-22	TG Therapeutics	TGTX	ublituximab	Treatment for patients with relapsing forms of multiple sclerosis (RMS)
05-31-22	PDUFA Date Added	11-30-22	Y-mabs Therapeutics	YMAB	omburtamab	Treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma
05-25-22	PDUFA Date Added	1-11-23	Phathom Therapeutics	PHAT	vonoprazan	Treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn
05-25-22	CRL Issued	05-24-22	Verrica Pharmaceuticals	VRCA	VP-102	Treatment of molluscum contagiosum (molluscum)
05-24-22	Approval Announced	05-16-22	Mannkind Corporation	MNKD	inhaled treprostinil	Treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)
05-23-22	PDUFA Date Added	3-23-22	Biohaven Pharmaceuticals	BHVN	zavegepant	Acute treatment of migraine in adults
05-23-22	PDUFA Date Added	11-28-22	Immunogen	IMGN	mirvetuximab	Treatment of patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments
05-16-22	PDUFA Date Added	11-17-22	Travere Therapeutics	TVTX	sparsentan	Treatment of IgA nephropathy (IgAN)
05-16-22	PDUFA Date Added	10-8-22	scPharmaceuticals	SCPH	furosemide	Treatment of congestion in patients with worsening heart failure
05-06-22	Extension of PDUFA Date	08-06-22	Pfizer	PFE	relugolix	Management of moderate to severe pain associated with endometriosis
05-04-22	PDUFA Date Added	08-04-22	AstraZeneca	AZN	durvalumab	Treatment of locally advanced or metastatic biliary tract cancer (BTC) in combination with standard of care chemotherapy
05-03-22	Approval Announced	05-03-22	Phathom Pharmaceuticals	PHAT	vonoprazan	Treatment of adults with H pylori
05-02-22	ADCOM Added	06-17-22	Acadia Pharmaceuticals	ACAD	pimavanserin	Treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
05-02-22	CRL Issued	04-30-22	Coherus BioSciences	CHRS	toripalimab	In combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy
05-02-22	CRL Issued	04-30-22	Axsome Therapeutics	AXSM	meloxicam-rizatriptan	Acute treatment of migraine
04-29-22	Approval Announced	04-29-22	Supernus Pharmaceuticals	SUPN	viloxazine	Treatment of attention-deficit hyperactivity disorder (ADHD) in adult patients
04-28-22	Approval Announced	04-28-22	Bristol-Myers Squibb	BMY	mavacamten	Treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
04-27-22	PDUFA Date Added	09-23-22	Fennec Pharmaceuticals	FENC	sodium thiosulfate	Prevention of platinum-induced ototoxicity in pediatric patients one month to <18 years of age with localized, non-metastatic, solid tumors
04-25-22	Approval Announced	04-26-21	Sol-Gel Technologies	SLGL	benzoyl peroxide	Treatment of inflammatory lesions of rosacea
04-21-22	PDUFA Date Added	09-08-22	Revance Therapeutics	RVNC	DaxibotulinumtoxinA	Treatment of moderate to severe glabellar lines
04-15-22	Application Withdrawn	06-25-22	TG Therapeutics	TGTX	ublituximab in combination with umbralisib	Treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
04-11-22	PDUFA Date Added	09-09-22	Spectrum Pharmaceuticals	SPPI	eflapegrastim	To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
04-06-22	Approval Announced	04-05-22	BioXcel Therapeutics	BTAI	BXCL501	Acute treatment of agitation associated with schizophrenia and bipolar disorders I and II
04-04-22	PDUFA Date Added	10-4-22	Roche	RHHBY	tocilizumab	Treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation
04-04-22	PDUFA Date Added	08-03-22	Regeneron Pharmaceuticals	REGN	dupilumab	Treatment of adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE)
04-04-22	Extension of PDUFA Date	07-14-22	Alnylam Pharmaceuticals	ALNY	vutrisiran	Treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults
04-01-22	Extension of PDUFA Date	07-01-22	Merck	MRK	Pneu-Ped	Prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age
03-30-22	CRL Issued	03-29-22	Akebia Therapeutics	AKBA	vadadustat	Treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis
03-25-22	PDUFA Date Added	09-28-22	CorMedix	CRMX	neutrolin	Reduction of catheter-related bloodstream infections (CRBSIs) in patients with renal failure who are receiving chronic hemodialysis via a central venous catheter
03-23-22	Approval Announced	03-28-22	Novartis	NVS	177Lu-PSMA-617	Treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting
03-21-22	Approval Announced	03-28-22	Merck	MRK	pembrolizumab	Treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
03-18-22	Approval Announced	03-19-22	Bristol-Myers Squibb	BMY	relatlimab and nivolumab	Treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma
03-18-22	Approval Announced	03-20-22	Marinus Pharmaceuticals	MRNS	ganaxolone	Treatment of seizures associated with CDKL5 deficiency disorder (CDD)
03-14-22	Extension of PDUFA Date	07-18-22	Incyte	INCY	ruxolitinib cream	Treatment of vitiligo
03-11-02	Approval Announced	03-30-22	AstraZeneca	AZN	olaparib	Adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery
03-10-22	ADCOM Added	04-22-22	TG Therapeutics	TGTX	ublituximab in combination with umbralisib	Treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
03-09-22	PDUFA Date Added	08-04-22	Acadia Pharmaceuticals	ACAD	pimavanserin	Treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
03-07-22	PDUFA Date Added	07-07-22	Horizon Therapeutics	HZNP	pegloticase	Treatment of patients with uncontrolled gout in combination with methotrexate
03-03-22	Extension of PDUFA Date	06-25-22	TG Therapeutics	TGTX	ublituximab in combination with umbralisib	Treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
03-01-22	PDUFA Date Added	10-6-22	Alnylam Pharmaceuticals	ALNY	lumasiran	Reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1)
03-01-22	Approval Announced	02-28-22	Johnson and Johnson/Legend Biotech	JNJ/LEGN	ciltacabtagene autoleucel	Treatment of relapsed/refractory multiple myeloma
03-01-22	Approval Announced	02-28-22	CTI BioPharma	CTIC	pacritinib	Treatment for myelofibrosis patients with severe thrombocytopenia
03-01-22	CRL Issued	02-28-22	Gilead Sciences	GILD	lenacapavir	Treatment of multi-drug resistant HIV-1 infection in heavily treatment-experienced (HTE) patients in combination with other antiretroviral agents
02-28-22	CRL Issued	02-28-22	Amryt Pharma	AMYT	oleogel-S10	Treatment of Epidermolysis Bullosa (“EB”)
02-25-22	CRL Issued	02-25-22	Reata Pharmaceuticals	RETA	bardoxolone	Treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome
02-24-22	Extension of PDUFA Date	06-16-22	Rhythm Pharmaceuticals	RYTM	setmelanotide	Treatment of patients with Bardet-Biedl syndrome (BBS) or Alström syndrome
02-22-22	PDUFA Date Added	10-22-22	BeiGene	BGNE	zanubrutinib	Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
02-22-22	PDUFA Date Added	10-1-22	Supernus Pharmaceuticals	SUPN	apomorphine	Treatment of motor fluctuations (OFF episodes) in pParkinson's disease
02-17-22	Approval Announced	02-17-22	Agios	AGIO	mitapivat	Treatment of adults with pyruvate kinase (PK) deficiency
02-16-22	ADCOM Added	03-30-22	Amylyx	AMLX	AMX0035	Treatment of amyotrophic lateral sclerosis (ALS)
02-16-22	PDUFA Date Added	06-29-22	Amylyx	AMLX	AMX0035	Treatment of amyotrophic lateral sclerosis (ALS)
02-15-22	PDUFA Date Added	12-14-22	Mirati Therapeutics	MTRX	adagrasib	Treatment of patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy
02-11-22	PDUFA Date Added	11-24-22	Spectrum Pharmaceuticals	SPPI	poziotinib	Treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations
02-10-22	PDUFA Date Added	06-09-22	Regeneron Pharmaceuticals	REGN	dupilumab	Add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
02-04-22	PDUFA Date Added	11-30-22	Cytokinetics	CYTK	omecamtiv mecarbil	Treatment of heart failure with reduced ejection fraction
02-03-22	PDUFA Date Added	03-28-22	Antares Pharma	ATRS	testosterone undecanoate	Treatment for testosterone replacement therapy
01-26-22	Approval Announced	02-23-22	Immunocore	IMCR	tebentafusp	Treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM)
01-25-22	PDUFA Date Added	07-25-22	PTC Therapeutics	PTCT	risdiplam	Treatment of pre-symptomatic infants under 2 months old with spinal muscular atrophy (SMA)
01-24-22	CRL Issued	03-21-22	Merck	MRK	gefapixant	Treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults
01-21-22	CRL Issued	01-04-22	OPKO Health	OPK	somatrogon	Treatment of pediatric patients with growth hormone deficiency
01-19-22	PDUFA Date Added	09-19-22	Regeneron Pharmaceuticals	REGN	cemiplimab	Treatment on first-line advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy
01-18-22	Extension of PDUFA Date	08-19-22	bluebird Bio	BLUE	betibeglogene autotemcel	Treatment of adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions
01-18-22	Extension of PDUFA Date	09-16-22	bluebird Bio	BLUE	eli-cel	Gene therapy for cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age
01-14-22	Approval Announced	07-27-21	Pfizer	PFE	abrocitinib	Treatment of moderate to severe atopic dermatitis in patients greater than 12 years and older
01-11-22	ADCOM Added	03-09-22	bluebird Bio	BLUE	betibeglogene autotemcel	Treatment of adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions
01-03-22	PDUFA Date Added	06-27-22	Spero Therapeutics	SPRO	tebipenem	Treatment in adult patients with complicated urinary tract infections (cUTI)
12-30-21	Approval Announced	01-01-22	Strongbridge Biopharma	SBBP	levoketoconazole	Treatment of endogenous Cushing's syndrome
12-22-21	PDUFA Date Added	07-29-22	Arcutis Biotherapeutics	ARQT	roflumilast cream	Treatment of psoriasis in adults and adolescents
12-22-21	Approval Announced	01-01-22	Alnylam Pharmaceuticals	ALNY	inclisiran	Treatment for hyperlipidemia in adults with high low-density lipoprotein cholesterol (LDL-C) who were otherwise on a maximum dose of a statin
12-22-21	Approval Announced	01-01-22	Novartis	NVS	inclisiran	Treatment for hyperlipidemia in adults with high low-density lipoprotein cholesterol (LDL-C) who were otherwise on a maximum dose of a statin
12-21-21	Approval Announced	01-24-22	GlaxoSmithKline	GSK	cabotegravir	Prevention of HIV for individuals at risk of sexually acquired HIV-1 infection
12-20-21	Approval Announced	12-17-21	Intra-Cellular Therapies	ITCI	lumateperone	Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate
12-20-21	PDUFA Date Added	06-17-22	bluebird Bio	BLUE	eli-cel	Gene therapy for cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age
12-20-21	Approval Announced	12-19-21	Amgen	AMGN	apremilast	Treatment of adults with mild-to-moderate plaque psoriasis
12-17-21	Approval Announced	12-25-21	Global Blood Therapeutics	GBT	voxelotor	Treatment of sickle cell disease (SCD) in children ages 4 to 11 years
12-17-21	Approval Announced	01-07-22	Amgen	AMGN	tezepelumab	Treatment of asthma
12-15-21	PDUFA Date Added	05-24-22	Verrica Pharmaceuticals	VRCA	VP-102	Treatment of molluscum contagiosum (molluscum)
12-15-21	Approval Announced	12-15-21	Calliditas Therapeutics	CALT	cefecon	Treatment of IgA nephropathy
12-15-21	Approval Announced	12-23-21	Bristol-Myers Squibb	BMY	abatacept	Prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT)
12-15-21	Approval Announced	06-18-21	Abbvie	ABBV	upadacitinib	Treatment of adult patients with active psoriatic arthritis
12-14-21	PDUFA Date Added	09-28-22	TG Therapeutics	TGTX	ublituximab	Treatment for patients with relapsing forms of multiple sclerosis (RMS)
12-13-21	Approval Announced	12-12-21	Veru	VERU	Tadfin	Treatment of Lower Urinary Tract Symptoms Caused by Benign Prostatic Hyperplasia (BPH)
12-07-21	Approval Announced	12-07-21	Dare Biosciences	DARE	DARE-BV1	Treatment of bacterial vaginosis
12-01-21	PDUFA Date Added	04-01-22	Merck	MRK	Pneu-Ped	Prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age
12-01-21	PDUFA Date Added	03-25-22	Zogenix	ZGNX	fenfluramine	Treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
12-01-21	Approval Announced	11-30-21	VBI Vaccines	VBIV	Sci-B-Vac	Prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults
12-01-21	CRL Issued	11-30-21	BeyondSpring	BYSI	plinabulin/G-CSF	Prevention of chemotherapy-induced neutropenia (CIN)
12-01-21	Extension of PDUFA date	04-05-22	BioXcel Therapeutics	BTAI	BXCL501	Acute treatment of agitation associated with schizophrenia and bipolar disorders I and II
11-30-21	Extension of PDUFA date	02-28-22	CTI BioPharma	CTIC	pacritinib	Treatment for myelofibrosis patients with severe thrombocytopenia
11-30-21	PDUFA Date Added	03-30-22	AstraZeneca	AZN	olaparib	Adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery
11-29-21	CRL Issued	11-27-21	Fennec Pharmaceuticals	FENC	sodium thiosulfate	Prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors
11-23-21	Extension of PDUFA date	02-28-22	Amryt Pharma	AMYT	oleogel-S10	Treatment of Epidermolysis Bullosa (“EB”)
11-22-21	PDUFA Date Added	09-13-22	ObsEva	OBSV	linzagolix	Management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women
11-22-21	PDUFA Date Added	05-20-22	bluebird Bio	BLUE	betibeglogene autotemcel	Treatment of adult, adolescent and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell (RBC) transfusions
11-19-21	Extension of PDUFA date	04-28-22	Bristol-Myers Squibb	BMY	mavacamten	Treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
11-19-21	Approval Announced	11-20-21	Biomarin Pharmaceuticals	BMRN	vosoritide	Treatment of achondroplasia
11-18-21	Approval Announced	12-10-21	Merck	MRK	pembrolizumab	Treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney), or following nephrectomy and resection of metastatic lesions
11-15-21	PDUFA Date Added	03-16-22	Rhythm Pharmaceuticals	RYTM	setmelanotide	Treatment of patients with Bardet-Biedl syndrome (BBS) or Alström syndrome
11-08-21	PDUFA Date Added	05-03-22	Phathom Pharmaceuticals	PHAT	vonoprazan	Treatment of adults with H pylori
11-08-21	Approval Announced	11-07-21	Liquidia	LQDA	treprostinil inhalation	Treatment of pulmonary arterial hypertension
11-08-21	Approval Announced	11-06-21	ETON Pharmaceuticals	ETON	Topiramate solution	Three neurologic indications
11-01-21	Extension of PDUFA date	02-28-22	Johnson and Johnson/Legend Biotech	JNJ/LEGN	ciltacabtagene autoleucel	Treatment of relapsed/refractory multiple myeloma
11-01-21	PDUFA Date Added	06-30-22	Teva Pharmaceuticals	TEVA	risperidone extended release injectable suspension	Treatment of schizophrenia
11-01-21	PDUFA Date Added	04-30-22	Incyte	INCY	parsaclisib	Treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma
11-01-21	PDUFA Date Added	04-02-22	Coherus BioSciences	CHRS	toripalimab	In combination with gemcitabine and cisplatin for the first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy
10-25-21	CRL Issued	10-28-21	Eyenovia	EYEN	MydCombi	Use in eye exams
10-25-21	Approval Announced	10-30-21	Clearside Biomedical	CLSD	triamcinolone injection	Treatment of macular edema associated with uveitis
10-22-21	BLA Withdrawn	12-16-21	Agenus	AGEN	balstilimab	Treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
10-18-21	CRL Issued	10-17-21	Omeros Corporation	OMER	narsoplimab	Treatment of hematopoetic stem cell transplant associated thrombotic microangiopathy
10-18-21	Approval Announced	10-17-21	Oyster Point Pharma	OYST	varenicline	Treatment of signs and symtpoms or dry eye disease
10-18-21	Approval Announced	11-12-21	Adamis Pharmaceuticals	ADMP	naloxone	Treatment of opioid overdose
10-15-21	CRL Issued	10-16-21	MannKind	MNKD	treprostinil inhalation	Treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)
10-15-21	CRL Issued	11-25-20	Revance	RVNC	DaxibotulinumtoxinA	Treatment of moderate to severe glabellar (frown) lines
10-15-21	Approval Announced	12-01-21	Roche	RHHBY	atezolizumab	Adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%
10-11-21	Approval Announced	10-18-21	Occular Therapeutics	OCUL	Dextenza	Treatment of ocular itching associated with allergic conjunctivitis
10-08-21	PDUFA Date Added	11-21-21	Takeda Pharmaceuticals	TAK	maribavir	Treatment of CMV infection and disease refractory to treatment in patients post-transplant
10-08-21	Approval Announced	10-07-21	ChemoCentryx	CCXI	avacopan	Treatment of ANCA-Associated Vasculitis
10-07-21	PDUFA Date Added	06-05-22	Acer Therapeutics	ACER	sodium phenylbutyrate	Treatment of patients with Urea Cycle Disorders (UCDs)
10-01-21	Approval Announced	10-01-21	Gilead	GILD	brexucabtagene autoleucel	Treatment of adult patients with relapsed or refractory B-cell precursor ALL
10-01-21	PDUFA Date Added	08-22-22	Coherus BioSciences	CHRS	ranibizumab biosimilar	Lucentis biosimilar
09-29-21	PDUFA Date Added	07-29-22	Amicus Therapeuticss	FOLD	cipaglucosidase	Treatment of Pompe Disease
09-29-21	PDUFA Date Added	05-29-22	Amicus Therapeuticss	FOLD	miglustat	Treatment of Pompe Disease
09-29-21	Approval Announced	09-29-21	Mirum Pharmaceuticals	MIRM	maralixibat	Treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older
09-28-21	PDUFA Date Added	01-30-22	Regeneron Pharmaceuticals	REGN	cemiplimab	Treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy
09-28-21	PDUFA Date Added	01-24-22	GlaxoSmithKline	GSK	cabotegravir	Prevention of HIV for individuals at risk of sexually acquired HIV-1 infection
09-27-21	PDUFA Date Added	05-28-22	Bristol-Myers Squibb	BMY	nivolumab and ipilimumab	Treatments of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
09-24-21	Extension of PDUFA date	01-04-22	OPKO Health	OPK	somatrogon	Treatment of pediatric patients with growth hormone deficiency
09-22-21	Approval Announced	09-22-21	Incyte Corporation	INCY	ruxolitinib	Treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older
09-21-21	PDUFA Date Added	02-28-21	Gilead Sciences	GILD	lenacapavir	Treatment of multi-drug resistant HIV-1 infection in heavily treatment-experienced (HTE) patients in combination with other antiretroviral agents
09-21-21	Approval Announced	10-21-21	Regeneron	REGN	dupilumab	Add-on treatment of uncontrolled moderate-to-severe asthma in children aged six to 11 years
09-21-21	Approval Announced	09-21-21	Incyte Corporation	INCY	Ruxolitinib cream	Treatment of atopic dermatitis
09-20-21	PDUFA Date Added	03-20-22	Marinus Pharmaceuticals	MRNS	ganaxolone	Treatment of seizures associated with CDKL5 deficiency disorder (CDD)
09-20-21	PDUFA Date Added	03-19-22	Bristol-Myers Squibb	BMY	relatlimab and nivolumab	Treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma
09-20-21	Approval Announced	10-10-21	Seagen	SGEN	tisotumab vedotin	Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
09-20-21	CRL Issued	09-23-21	Verrica Pharmaceuticals	VRCA	VP-102	Treatment of molluscum contagiosum (molluscum)
09-17-21	Approval Announced	12-04-21	Exelixis	EXEL	cabozantinib	Treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory
09-15-21	Approval Announced	09-19-21	BeiGene	BGNE	zanubrutinib	Treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy
09-14-21	PDUFA Date Added	04-30-22	Axsome Therapeutics	AXSM	meloxicam-rizatriptan	Acute treatment of migraine
09-14-21	Extension of PDUFA date	12-15-21	Calliditas Therapeutics	CALT	cefecon	Treatment of IgA nephropathy
09-13-21	PDUFA Date Added	07-12-22	BeiGene	BGNE	tislelizumab	Treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy
09-09-21	PDUFA Date Added	05-06-22	Pfizer	PFE	relugolix	Management of moderate to severe pain associated with endometriosis
09-07-21	PDUFA Date Added	12-25-21	Global Blood Therapeutics	GBT	voxelotor	Treatment of sickle cell disease (SCD) in children ages 4 to 11 years
09-03-21	PDUFA Date Added	04-29-22	Supernus Pharmaceuticals	SUPN	viloxazine	Treatment of attention-deficit hyperactivity disorder (ADHD) in adult patients
09-01-21	Approval Announced	10-18-21	BeiGene	BGNE	zanubrutinib	Treatment of adult patients with Waldenström’s Macroglobulinemia (WM)
08-25-21	Approval Announced	09-25-21	Ascendis Pharma	ASND	lonapegsomatropin	Treatment for pediatric growth hormon deficiency
08-24-21	PDUFA Date Added	02-23-22	Immunocore	IMCR	tebentafusp	Treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM)
08-23-21	PDUFA Date Added	12-23-21	Bristol-Myers Squibb	BMY	abatacept	Prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT)
08-23-21	FDA Defers Decision	08-22-21	Axsome Therapeutics	AXSM	dextromethorphan-bupropion	Treatment of major depressive disorder (MDD)
08-23-21	Approval Announced	01-16-22	Pfizer/BioNTech	PFE	COVID Vaccine	Prevention of COVID-19 in individuals 16 years of age and older
08-23-21	Approval Announced	08-23-21	Cara Therapeutics	CARA	Korsuva	Treatment of moderate-to-severe pruritus in hemodialysis patients
08-20-21	Approval Announced	09-03-21	Bristol-Myers Squibb	BMY	nivolumab	Adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma
08-17-21	PDUFA Date Added	02-17-22	Agios	AGIO	mitapivat	Treatment of adults with pyruvate kinase (PK) deficiency
08-17-21	Approval Announced	-	GlaxoSmithKline	GSK	dostarlimab	Treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options
08-14-21	Approval Announced	08-24-21	Pfizer	PFE	TicoVac	Prevention of tick-borne encephalitis
08-13-21	Approval Announced	09-15-21	Merck	MRK	belzutifan	Treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC)
08-13-21	CRL Issued	08-18-21	Sesen	SESN	Vicineum	Treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
08-12-21	Approval Announced	08-12-21	Jazz Pharmaceuticals	JAZZ	sodium oxybate	Idiopathic hypersomnia
08-12-21	Approval Announced	08-25-21	Merck	MRK	pembrolizumab	First-line treatment of patients with advanced renal cell carcinoma (RCC)
08-12-21	Approval Announced	08-26-21	Merck	MRK	lenvatinib	First-line treatment of patients with advanced renal cell carcinoma (RCC)
08-10-21	PDUFA Date Added	12-10-21	Merck	MRK	pembrolizumab	Treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney), or following nephrectomy and resection of metastatic lesions
08-10-21	PDUFA Date Added	03-28-21	Merck	MRK	pembrolizumab	Treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation

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