FDA accepts for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lung disease.
Federal Register notice: FDA withdraws a draft guidance entitled Applications for Premarket Review of New Tobacco Products.
FDA clears a Canon Medical Systems 510(k) for the Aquilion Exceed LB CT system.
PhRMA asks for changes to an FDA draft guidance on biosimilarity and interchangeability.
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...