FDA clears a Becton Dickinson 510(k) for what it describes as a novel blood collection device that gathers blood samples from a fingerstick that produ...
Sen. Elizabeth Warren and Rep. Jan Schakowsky reintroduce their bill to establish a generic drug manufacturing operation within HHS.
FDA accepts for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimers disease.
Regeneron says it will submit a BLA to FDA this year for its linvoseltamab multiple myeloma drug based on successful Phase 1/2 trial results.
Reps. Eshoo and McCaul introduce bipartisan legislation to strengthen pediatric drug development.
Zydus Pharmaceuticals asks FDA to take multiple actions against BPI Labs unapproved methylene blue injection product.
Bausch & Lomb asks FDA to impose conditions on any ANDAs for a generic form of its macular edema drug Xipere.
Federal Register notice: FDA makes available a final guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Presc...
