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.
Baxter recalls its AK 98 dialysis machines based on recent recalls by other manufacturers related to the potential risk of exposure to hazardous chemi...
