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Edwards Lifesciences Recalls Optisite Arterial Cannula

[ Price : $8.95]

Edwards Lifesciences recalls its Optisite Arterial Cannula due to complaints received about its 3mm to 4mm section wire exposed/pr...

FDA Conducting Benefit-Risk Modeling on Covid Vaccines

[ Price : $8.95]

FDA leaders say that the agency is currently conducting benefit-risk modeling studies based on the evolving risk of Covid-19 sever...

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Milestone Pharma Resubmits Cardamyst NDA

[ Price : $8.95]

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

Avanos Recalls Ventilator Suction Devices

[ Price : $8.95]

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