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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...

Winrevair Study Stopped on Positive Data: Merck

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

Jazz Biliary Tract Cancer BLA Approved

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FDA grants Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii) for treating unresectable or metasta...

2 Orthopedic Non-Spinal Bone Guidances Posted

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FDA posts two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers.