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Weekly FDA Updates – March 2nd

Last Updated on March 7, 2020 by Chris Stang


This week we saw the table set for many future PDUFAs, with a relatively quiet week with regards to approvals. That being said, we have several upcoming PDUFA dates.

Upcoming PDUFAs Next Week:

Bristol-Myers Squibb’s (BMY) sBLA for nivolumab in combination with ipilimumab for the treatment of advanced hepatocellular carcinoma previously treated with sorafenib has a goal action date of 3/10//2020.

New Approvals:

On Monday 3/2/2020, the FDA approved Sanofi’s (SNY) isatuximab (Sarclisa) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

New PDUFA Dates:

Eagle Pharmaceuticals (EGRX) – PDUFA Date of 7-8-20 for dantrolene for the treatment of exertional heat stroke.

Trevena (TRVN) – PDUFA Date of 8-7-20 for oliceridine for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted.

Lipocine (LPCN) – PDUFA Date of 8-28-20 for oral testosterone as testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

MorphoSys (MOR) – Priority Review PDUFA Date of 8-30-20 for tafasitamab for the treatment of relapsed/refractory DLBCL.

Zosano (ZSAN) – PDUFA Date of 10-20-20 for transdermal zolmitriptan for the treatment of difficult to treat migraines.

Urovant (UROV) – PDUFA Date of 12-26-20 for vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Eli Lilly (LLY) and Pfizer (PFE) – PDUFA Date of 12-31-20 for tanezumab for chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics.

See our full FDA PDUFA calendar at https://biotechwinners.com/fda-pdufa-calendar/



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