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...
FDA issues Applied Therapeutics a complete response letter on its NDA for govorestat and its use for treating classic galactosemia.
FDA approves a Mentor Worldwide PMA for its MemoryGel Enhance Breast Implants for reconstruction breast surgery in post-mastectomy women.
FDA publishes a guidance to help sponsors planning to use circulating tumor DNA as a biomarker in some cancer trials.
