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Human Drugs

Follow-up Testing for Ames-Positive Drugs: Guide

FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Huma...

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Human Drugs

6 Observations on Regeneron FDA-483

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

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Human Drugs

Alnylam Files sNDA for Vutrisiran

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

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Human Drugs

BridgeBio Gets Transthyretin Amyloidosis Drug OK

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

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Human Drugs

Cassava Stops Controversial Alzheimers Drug Developoment

Cassava Sciences discontinues the development of its Alzheimers disease drug simufilam after announcing disappointing topline data from the Phase 3 Re...

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Human Drugs

Winrevair Study Stopped on Positive Data: Merck

Merck stops early its Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension due to positive stud...

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FDA General

Trump Selects Johns Hopkins Makary as FDA Head

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

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Human Drugs

Device EtO Sterilization Transitional Enforcement Policy

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

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Medical Devices

Zimmer Biomet Cementless Partial Knee OKd

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