FDA Calendar
Our careful research helps bring the power of trading and investing in biotechnology to your fingertips. In the world of biotechnology, knowing the competition is just as important as knowing your holdings!
Our top table displays upcoming, expected FDA events while the second table documents previous FDA events.
| - | Company | Ticker | Drug | Indication | Event Type | Priority Review |
|---|---|---|---|---|---|---|
| 05-29-21 | ETON Pharmaceuticals | ETON | ET-104 | Treatment of partial seizures in patients with epilepsy | NDA | No |
| 08-22-21 | Axsome Therapeutics | AXSM | dextromethorphan-bupropion | Treatment of major depressive disorder (MDD) | NDA | Yes |
| 10-15-21 | Avadel Pharmaceuticals | AVDL | sodium oxybate | Treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy | NDA | No |
| 12-23-21 | Aquestive Therapeutics | AQST | diazepam | Treatment of seizure clusters | NDA | No |
| 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 | BLA | Yes |
| 05-24-22 | Verrica Pharmaceuticals | VRCA | VP-102 | Treatment of molluscum contagiosum (molluscum) | NDA | No |
| 05-28-22 | Bristol-Myers Squibb | BMY | nivolumab and ipilimumab | Treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) | sBLA | No |
| 06-05-22 | Acer Therapeutics | ACER | sodium phenylbutyrate | Treatment of patients with Urea Cycle Disorders (UCDs) | NDA | No |
| 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 | sBLA | Yes |
| 06-16-22 | Rhythm Pharmaceuticals | RYTM | setmelanotide | Treatment of patients with Bardet-Biedl syndrome (BBS) or Alström syndrome | sNDA | Yes |
| 06-17-22 | Acadia Pharmaceuticals | ACAD | pimavanserin | Treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis | ADCOM | No |
| 06-24-22 | Bristol-Myers Squibb | BMY | lisocabtagene maraleucel | Treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) after failure of first-line therapy | sBLA | Yes |
| 06-27-22 | Spero Therapeutics | SPRO | tebipenem | Treatment in adult patients with complicated urinary tract infections (cUTI) | NDA | Yes |
| 06-27-22 | Merck/Bristol-Myers Squibb | MRK/BMY | luspatercept | Treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia | sBLA | Yes |
| 06-29-22 | Amylyx | AMLX | AMX0035 | Treatment of amyotrophic lateral sclerosis (ALS) | NDA | Yes |
| 06-30-22 | Teva Pharmaceuticals | TEVA | risperidone extended release injectable suspension | Treatment of schizophrenia | NDA | No |
| 07-01-22 | Merck | MRK | Pneu-Ped | Prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age | sBLA | Yes |
| 07-07-22 | Horizon Therapeutics | HZNP | pegloticase | Treatment of patients with uncontrolled gout in combination with methotrexate | sBLA | Yes |
| 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 | BLA | No |
| 07-13-22 | Bristol-Myers Squibb | BMY | nivolumab | Neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC) | sBLA | Yes |
| 07-14-22 | Alnylam Pharmaceuticals | ALNY | vutrisiran | Treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults | BLA | No |
| 07-18-22 | Incyte | INCY | ruxolitinib cream | Treatment of vitiligo | sNDA | No |
| 07-25-22 | PTC Therapeutics | PTCT | risdiplam | Treatment of pre-symptomatic infants under 2 months old with spinal muscular atrophy (SMA) | sNDA | Yes |
| 07-29-22 | Arcutis Biotherapeutics | ARQT | roflumilast cream | Treatment of psoriasis in adults and adolescents | NDA | No |
| 08-03-22 | Regeneron Pharmaceuticals | REGN | dupilumab | Treatment of adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE) | sBLA | Yes |
| 08-04-22 | Acadia Pharmaceuticals | ACAD | pimavanserin | Treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis | sNDA | No |
| 08-04-22 | AstraZeneca | AZN | durvalumab | Treatment of locally advanced or metastatic biliary tract cancer (BTC) in combination with standard of care chemotherapy | sBLA | Yes |
| 08-06-22 | Pfizer | PFE | relugolix | Management of moderate to severe pain associated with endometriosis | sNDA | No |
| 08-17-22 | Provention Bio | PRVB | teplizumab | For the delay of clinical type 1 diabetes (T1D) in at-risk individuals | BLA | No |
| 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 | BLA | Yes |
| 08-22-22 | Coherus BioSciences | CHRS | ranibizumab biosimilar | Lucentis biosimilar | BLA | No |
| 08-29-22 | Amicus Therapeuticss | FOLD | miglustat | Treatment of Pompe Disease | NDA | No |
| 09-08-22 | Revance Therapeutics | RVNC | DaxibotulinumtoxinA | Treatment of moderate to severe glabellar lines | BLA | No |
| 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 | BLA | No |
| 09-10-22 | Bristol-Myers Squibb | BMY | deucravacitinib | Treatment of adults with moderate to severe plaque psoriasis | NDA | No |
| 09-13-22 | ObsEva | OBSV | linzagolix | Management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women | NDA | No |
| 09-16-22 | bluebird Bio | BLUE | eli-cel | Gene therapy for cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age | BLA | Yes |
| 09-19-22 | Regeneron Pharmaceuticals | REGN | cemiplimab | Treatment on first-line advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy | sBLA | No |
| 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 | NDA | No |
| 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 | NDA | No |
| 09-28-22 | TG Therapeutics | TGTX | ublituximab | Treatment for patients with relapsing forms of multiple sclerosis (RMS) | BLA | No |
| 10-1-22 | Supernus Pharmaceuticals | SUPN | apomorphine | Treatment of motor fluctuations (OFF episodes) in pParkinson's disease | NDA | No |
| 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 | sNDA | Yes |
| 10-6-22 | Alnylam Pharmaceuticals | ALNY | lumasiran | Reduction of plasma oxalate in the treatment of patients with advanced primary hyperoxaluria type 1 (PH1) | sNDA | No |
| 10-8-22 | scPharmaceuticals | SCPH | furosemide | Treatment of congestion in patients with worsening heart failure | NDA | No |
| 10-22-22 | BeiGene | BGNE | zanubrutinib | Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) | sNDA | No |
| 10-29-22 | Amicus Therapeuticss | FOLD | cipaglucosidase | Treatment of Pompe Disease | BLA | No |
| 11-17-22 | Travere Therapeutics | TVTX | sparsentan | Treatment of IgA nephropathy (IgAN) | NDA | Yes |
| 11-24-22 | Spectrum Pharmaceuticals | SPPI | poziotinib | Treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations | NDA | No |
| 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 | BLA | Yes |
| 11-30-22 | Cytokinetics | CYTK | omecamtiv mecarbil | Treatment of heart failure with reduced ejection fraction | NDA | No |
| 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 | NDA | No |
| 3-23-22 | Biohaven Pharmaceuticals | BHVN | zavegepant | Acute treatment of migraine in adults | NDA | No |
Recent FDA Activity
| Date | Action | Event Date | Company | Ticker | Drug | Indication |
|---|---|---|---|---|---|---|
| 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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