Novartis says it is planning a regulatory submission to FDA and other agencies worldwide in the first half of this year for iptocopan to treat paroxys...
Federal Register notice: FDA seeks comments on an information collection extension Animal Drug and Animal Generic Drug User Fee Programs.
FDA releases the form FDA-483 with eight observations from an inspection at Reykjavik, Iceland-based Alvotech Hf.
Akorn through its bankruptcy (Chapter 7) trustee recalls various within-expiry human and animal products because the company has ceased all operations...
FDA approves a Vertex Pharmaceuticals supplemental NDA for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor) to include certain children...
FDA issues a warning about adverse event reports related to selective androgen receptor modulators (SARMs), which are often marketed as dietary supple...
FDA asks the Oncologic Drugs Advisory Committee whether an sNDA for AstraZenecas prostate cancer drug olaparib in combination with Janssens abirateron...
FDA lifts a 2021 Warning Letter to Medtronic that followed an inspection of the companys diabetes headquarters in Northridge, CA.
