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FDA OKs Emergents Anthrax Vaccine

[ Price : $8.95]

FDA approves an Emergent BioSolutions BLA for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for anthrax post-exposure prophylaxi...

Peter Stoll Guilty on Medical Device Felony Count

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Former medical device regulatory affairs specialist Peter Stoll pleads guilty on one felony count for distributing medical devices...

CDERs Rosemary Roberts is Retiring

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CDER Counterterrorism and Emergency Coordination Staff director Rosemary Roberts announces her retirement this month.

BIO Backs Rare Disease Endpoint Pilot

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The Biotechnology Innovation Organization says FDAs new Rare Disease Endpoint Advancement Pilot Program will provide greater clari...

FDA Clears BD Alaris Pump Troubles

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FDA signs off on a Becton, Dickinson 510(k) that was filed over two years ago to update the firms troubled BD Alaris Infusion Syst...

Wuxi Pharmaceutical FDA-483

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FDA releases the form FDA-483 with one observation from an inspection at Chinas Wuxi Sta Pharmaceutical contract manufacturing org...

Abiomed Recalls All Lots of 6 Heart Pumps

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Abiomed recalls all lots of six models of its Impella heart pump due to a potential risk for impeller blade destruction.

Vir Flu Vaccine Fails Phase 2 Trial

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The Vir Biotechnology VIR-2482 investigational influenza A monoclonal antibody vaccine fails to meet the primary and secondary end...

Dismiss Norwich Rifaximin Suit: FDA

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FDA tells the DC federal court there are five reasons why it should dismiss a Norwich suit seeking to force the agency to approve ...

MediView Surgical Augmented Reality Device Cleared

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FDA clears a MediView XR 510(k) for its XR90 augmented reality-based surgical visualization and navigation platform.