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Keeping Track: US FDA Approval Of Jazz Rylaze Addresses Shortage; MediWound, Cyclopharm Receive CRLs

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

Bad news outweighed the good for sponsors at the US Food and Drug Administration this past week. Two novel agents, NexoBrid and Technegas, received complete response letter, while Iterum Therapeutics plc’s oral sulopenem received a letter from the FDA that could suggest a CRL is in the offing. In the latest fallout from the agency’s review of “dangling” immuno-oncology accelerated approvals, Merck & Co., Inc.’s Keytruda lost a third-line gastric cancer claim.

On the more positive side of the ledger, the FDA cleared a new biologic product, Jazz Pharmaceuticals plc’s Rylaze, in just two months to address a global shortage

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