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Weekly FDA Updates – March 9th

Last Updated on March 14, 2020 by Chris Stang


This was a very volatile week secondary to fears and political developments regarding the spread of COVID-19. This was capped by a large pop on Friday following President Trump’s press conference. During this conference, he announced a national state of emergency over COVID-19, which included several financial benefits. Overall, we had a even more quiet week on the FDA front as productivity has slowly ground down.

Upcoming PDUFA Dates

March 25th, Bristol-Myers Squibb’s (BMY) ozanimod NDA for the treatment of relapsing forms of multiple sclerosis.

March 26th, IntelGenx’s (IGXT) RIZAPORT NDA for the treatment of acute migraines.

March 28th, Rockwell Medical’s (RTMI) TRIFERIC NDA for the treatment of iron deficiency anemia in patients with end-stage renal disease.

New Approval’s

On March 11th, the FDA approved Bristol-Myers Squibb’s (BMY) nivolumab plus ipilimumab for the treatment of hepatcellular carcinoma (HCC) in patients who have previously treated with sorafenib. This approval was granted under the accelerated approval pathway and requires a confirmatory trial to confirm clinical benefit.

New PDUFA Dates

Athenex (ATNX) – FDA PDUFA date of 12/30/2020 for tirbanibulin for the treatment of actinic keratosis.

Mylan (MYL) – FDA BsUFA date of 12/27/2020 for MYL-1402O, a biosimiliar agent to bavacizumab (Avastin).

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


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