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PhRMA Wants More Complete Interchangeability Guidance

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PhRMA asks for changes to an FDA draft guidance on biosimilarity and interchangeability.

FDA Approves Cabenuva for HIV-1 Infection

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FDA approves ViiVs Cabenuva and Vocabria to treat HIV-1 infection in some adults.

FDA Accepts 2 Opdivo sBLAs for New Indications

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FDA accepts two sBLAs for new indications for Bristol-Myers Squibbs Opdivo and sets PDUFA goal dates in May.

FDA Clears 2 Siemens Digital Radiography Devices

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FDA clears a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Mu...

Impel NeuroPharma NDA for Migraine Drug

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FDA accepts for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migra...

Rule on Premarket Tobacco Product Application Requirements

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Federal Register notice: FDA issues a final rule that outlines requirements for premarket tobacco product applications and require...

Hahn Rejects Animal Biotech MOU

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Outgoing FDA commissioner Stephen Hahn says the agency does not support a last-minute policy restriction placed on FDA involving a...

Revised Proposal Requests for Reimporting Insulin

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Federal Register notice: FDA and HHS revise proposal requests for reimporting insulin and the personal importation of prescription...

FDA Denies Glaxo Zofran Petition

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FDA denies a GlaxoSmithKline petition asking the agency to review specified information about its Zofran and indicate whether ther...

FDA Approves Merck Verquvo for Heart Failure

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FDA approves Mercks Verquvo heart failure drug based on VICTORIA trial results.