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Axsome to File NDA on Narcolepsy Drug

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Based on just-reported Phase 3 trial data, Axsome Therapeutics says it will submit an NDA for on AXS-12 (reboxetine) and its use i...

Follow-up Testing for Ames-Positive Drugs: Guide

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FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To S...

6 Observations on Regeneron FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at Limerick, Ireland-based Regeneron Ireland Designated Act...

Trump Selects Johns Hopkins Makary as FDA Head

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President-elect Donald Trump names Johns Hopkins surgeon and public policy researcher Marty Makary as his nomination to be the nex...

Device EtO Sterilization Transitional Enforcement Policy

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FDA issues a final guidance entitled Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class 3...

Zimmer Biomet Cementless Partial Knee OKd

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FDA approves a Zimmer Biomet PMA supplement for its Oxford Cementless Partial Knee.

Alnylam Files sNDA for Vutrisiran

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FDA accepts for review an Alnylam Pharmaceuticals supplemental NDA for vutrisiran, an investigational RNAi therapeutic in developm...

BridgeBio Gets Transthyretin Amyloidosis Drug OK

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FDA approves a BridgeBio Pharma NDA for Attruby (acoramidis), a near-complete stabilizer of transthyretin for treating adults with...

Cassava Stops Controversial Alzheimers Drug Developoment

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Cassava Sciences discontinues the development of its Alzheimers disease drug simufilam after announcing disappointing topline data...