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.
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...
Former FDA Commissioner Scott Gottlieb predicts a difficult path for Robert F. Kennedy Jr. to win Senate confirmation as HHS secretary due to his extr...
Johnson & Johnson files two supplemental BLAs for Tremfya (guselkumab) for treating certain children with moderate-to-severe plaque psoriasis and acti...
