Federal Register notice: FDA sends to OMB an information collection revision entitled Time and Extent Applications (TEA) for Nonprescription Drug Prod...
FDA accepts for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimers disease.
FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug substances.
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.
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.
