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Merck Winrevair sBLA Seeks Updated Label on Risk Reduction

[ Price : $8.95]

FDA accepts for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update its label to reflect ...

FDA Rejects Capricor Duchenne Cell Therapy

[ Price : $8.95]

FDA issues Capricor Therapeutics a complete response on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy ...

Intuitive Vessel Sealer Cleared for da Vinci Devices

[ Price : $8.95]

FDA clears an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci sy...

Interchangeable Biosimilar Product Development Workshop

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FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future...

Complete Response Letters to be Posted in Real Time: FDA

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FDA commissioner Marty Makary pledges to release new complete response letters in real time.

Breakthrough Status for AI Prostate Treatment Planner

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FDA grants Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool to help treat...

Milestone Pharma Resubmits Cardamyst NDA

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FDA accepts for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered tre...

Avanos Recalls Ventilator Suction Devices

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Avanos Medical recalls its Ballard Closed Suction Systems due to sterilization concerns.

FDA Publishes Complete Response Letters

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FDA publishes redacted versions of over 200 complete response letters issued between 2020 and 2024 in a demonstration of its commi...

Makary Touts Successes in 1st Hundred Days

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FDA commissioner Martin Makary takes a 100-days-in-office victory lap, citing 32 initiatives that he says have been started to Mak...