FDA issues Capricor Therapeutics a complete response on its BLA for Deramiocel, a cell therapy candidate targeting cardiomyopathy associated with Duch...
FDA clears an Intuitive 510(k) for its Vessel Sealer Curved advanced energy instrumentation for use with its multiport da Vinci systems.
FDA announces a 9/19 scientific workshop to discuss the development of interchangeable biosimilar products to help identify future needs (e.g., guidan...
FDA commissioner Marty Makary pledges to release new complete response letters in real time.
FDA grants Artera a breakthrough device designation for its ArteraAI Prostate, an artificial intelligence-based tool to help treat patients with local...
FDA accepts for review a Milestone Pharmaceuticals NDA resubmission for Cardamyst (etripamil) nasal spray, a self-administered treatment for paroxysma...
Avanos Medical recalls its Ballard Closed Suction Systems due to sterilization concerns.
FDA publishes redacted versions of over 200 complete response letters issued between 2020 and 2024 in a demonstration of its commitment to radical tra...
