FDA approves ViiVs Cabenuva and Vocabria to treat HIV-1 infection in some adults.
FDA accepts two sBLAs for new indications for Bristol-Myers Squibbs Opdivo and sets PDUFA goal dates in May.
FDA clears a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Multix Impact VA20, a ...
FDA accepts for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migraine headaches with o...
Federal Register notice: FDA issues a final rule that outlines requirements for premarket tobacco product applications and requires manufacturers to m...
Federal Register notice: FDA and HHS revise proposal requests for reimporting insulin and the personal importation of prescription drugs.
FDA denies a GlaxoSmithKline petition asking the agency to review specified information about its Zofran and indicate whether there should be labeling...
FDA approves Mercks Verquvo heart failure drug based on VICTORIA trial results.