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FDA accepts for priority review a Merck supplemental BLA for Winrevair (sotatercept-csrk), seeking to update its label to reflect ...[ Price : $8.95]
FDA issues Capricor Therapeutics a complete response on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy ...[ 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...[ Price : $8.95]
FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future...[ Price : $8.95]
FDA commissioner Marty Makary pledges to release new complete response letters in real time.[ Price : $8.95]
FDA grants Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool to help treat...[ Price : $8.95]
FDA accepts for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered tre...[ Price : $8.95]
Avanos Medical recalls its Ballard Closed Suction Systems due to sterilization concerns.