FDA approves an Ascendis Pharma NDA for Yorvipath (palopegteriparatide) for treating hypoparathyroidism in adults.
FDA tells Humacyte it needs more time to complete the review of BLA for the acellular tissue-engineered vessel, indicated for treating vascular trauma...
Abiomed recalls (Class 1) certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed inspection.
FDA awards Kyverna Therapeutics a regenerative medicine advanced therapy designation for the companys CAR T-cell product candidate, KYV-101, and its u...
FDA approves an ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions.
Braun Medical recalls (Class 1) two lots of 0.9% sodium chloride for injection USP 1,000 mL due to the potential for particulate matter in the drug co...
FDA selects American College of Cardiology chief innovation officer Ami Bhatt to serve a four-year term as chair of the agencys recently created Digit...
Federal Register notice: FDA makes available a final guidance entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for t...
