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PhRMA asks for changes to an FDA draft guidance on biosimilarity and interchangeability.[ Price : $8.95]
FDA approves ViiVs Cabenuva and Vocabria to treat HIV-1 infection in some adults.[ Price : $8.95]
FDA accepts two sBLAs for new indications for Bristol-Myers Squibbs Opdivo and sets PDUFA goal dates in May.[ Price : $8.95]
FDA clears a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Mu...[ Price : $8.95]
FDA accepts for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migra...[ Price : $8.95]
Federal Register notice: FDA issues a final rule that outlines requirements for premarket tobacco product applications and require...[ Price : $8.95]
Outgoing FDA commissioner Stephen Hahn says the agency does not support a last-minute policy restriction placed on FDA involving a...[ Price : $8.95]
Federal Register notice: FDA and HHS revise proposal requests for reimporting insulin and the personal importation of prescription...