FDA warns New York, NY-based Applied Therapeutics about violations in its conduct of a clinical trial.
Federal Register notice: FDA issues a priority review voucher to PTC Therapeutics for its qualified rare pediatric disease product Kebilidi.
Federal Register notice: FDA reopens the comment period associated with a 10/21 public meeting on Advancing Smoking Cessation: Food and Drug Administr...
FDA accepts for review a Cytokinetics NDA for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy.
Baxter recalls its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to hazardous chemi...
Federal Register notice: FDA makes available a final guidance entitled Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development....
Federal Register notice: FDA seeks comments on an information collection extension entitled Financial Disclosure by Clinical Investigators.
Federal Register notice: FDA announces a 1/10 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a Seikagaku BLA for radicul...
