FDA commissioner Marty Makary says the agency is planning to release in the coming days a vaccine development framework to help with predictability fo...
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 warns Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be regulated as cosmetics...
Biotech executives, investors, and consultants say some companies are moving early clinical trials overseas due to fears of instability and slowness a...
FDA approves a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with locally advanced, un...
