Biotech Stocks Facing FDA Decision In August 2021

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As of this writing, the FDA has approved four novel drugs in the month of July, bringing the total number of approvals so far this year to 31.

Sanofi’s Fexinidazole, one of the 4 novel drugs approved this month, is the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness, a parasitic disease transmitted by the bite of an infected tse-tse fly.

The first drug for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis, Bylvay, developed by Alberio, scored FDA approval on July 20.

Bayer’s Kerendia received FDA approval on July 10, becoming the first and only nonsteroidal mineralocorticoid receptor antagonist proven to significantly slow chronic kidney disease progression and reduce cardiovascular risk in people with chronic kidney disease associated with type 2 diabetes.

Rezurock, developed by Kadmon Pharma, which won FDA approval on July 16, represents the first FDA-approved therapy for chronic GVHD patients who have failed multiple alternative treatment options.