An NPR report says FDA has received nearly 500 complaints about mental health issues patients associate with using semaglutide drugs such as Ozempic.
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) and its combination use with external beam radiotherapy plus con...
FDA grants orphan drug designation to Puma Biotechnologys small cell lung cancer investigative drug aliserib.
Federal Register notice: FDA reopens the comment period for the 4/4 notice entitled In-Home Disposal Systems for Opioid Analgesics; Request for Inform...
In an unusual move, FDA issues a statement about recent agency inspections at Novo Nordisks Clayton, NC manufacturing facility to quell concerns about...
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Conduct of Clinical Trials of Medical Products During Ma...
FDA grants Terumos MicroVention unit 510(k) clearance for its SOFIA EX 5F 115 cm intracranial support catheter for transradial access in addition to t...
FDA issues a complete response letter to an ARS Pharmaceuticals NDA for neffy, calling for a repeat-dose study.
