FDA publishes a guidance with recommendations for marketing submissions for Predetermined Change Control Plans for artificial intelligence-enabled dev...
FDA warns South Koreas LCC Ltd. about CGMP violations in its manufacturing of unapproved and misbranded over-the-counter drugs.
FDA grants Merck a breakthrough therapy designation for sacituzumab tirumotecan (sac-TMT) and its use in treating certain patients with non-small cell...
The House Select Subcommittee on the Coronavirus Pandemic faults many FDA actions and decisions in its 550-page report on lessons learned from the pan...
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.
