FDA extends by two months its review of a PharmaTher NDA for Ketarx (ketamine) that is seeking anesthesia, sedation, pain, mental health, neurological...
FDA commissioner Marty Makary agrees to testify 5/22 at a Senate appropriations subcommittee hearing on the agencys fiscal year 2026 budget request.
FDA commissioner Marty Makary announces a 5/20 roundtable discussion on the safety and necessity of talc as an additive in food, drug, and cosmetic pr...
FDA approves Amneals Brekiya, the only dihydrogotamine mesylate autoinjector available to treat migraine and cluster headaches in adults.
FDA accepts a BioCryst NDA for Orladeyo to be used in pediatric patients with hereditary angioedema.
Merck's Keytruda meets a Phase 3 clinical trial primary endpoint of progression-free survival for treating patients with platinum-resistant recurrent ...
FDA approves an Incyte supplemental BLA for Zynyz (retifanlimab-dlwr) in combination with carboplatin and paclitaxel for the first-line treatment of a...
FDA says it is delaying for three months the PDUFA action date for Biohavens troriluzole to treat spinocerebellar ataxia.
