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.
Keeping Track: US FDA Approval Of Jazz Rylaze Addresses Shortage; MediWound, Cyclopharm Receive CRLs
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.