FDA approves Mercks Keytruda (pembrolizumab) for use with carboplatin and paclitaxel in adult patients with primary advanced or recurrent endometrial ...
Federal Register notice: FDA makes available a final guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.
FDA posts a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA that provides information on how the agency intends to assign ...
FDA gives a one-item Form FDA-483 to Chugai Pharma Manufacturing Co. after inspecting the firms Utsunomiya, Tochigi, Japan facility 3/25 to 4/2.
Federal Register notice: FDA corrects a 5/23 notice announcing the availability of a draft revised guidance #115 (VICH GL22) entitled Studies to Evalu...
CDRH Digital Health Center of Excellence director Troy Tazbaz says that developing a medical device quality assurance practice for artificial intellig...
Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...
Takeda says data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) in Dravet syndrome and Lennox-Gastaut syndrome patients failed to meet t...
