CDER scientists are working to improve the bioavailability of generic drugs that do not dissolve well in water.
Federal Register notice: FDA issues a priority review voucher to Marinus Pharmaceuticals for gaining approval of a rare pediatric disease product appl...
Federal Register notice: FDA corrects an 8/17 notice on a 10/17-19 hearing request to review and vote on whether agency approval for Covis Makena (hyd...
FDA sends Alvotech a complete response letter on its proposed Humira biosimilar AVT02, citing inspection deficiencies at its Reykjavik, Iceland manufa...
FDA denies most requests in a Salix Pharmaceuticals petition asking for restrictions on approval of ANDAs citing its Xifaxin as the reference-listed d...
Bayer agrees to pay $40 million to the federal government and 20 states to resolve two whistleblower False Claims Act suits over three of its drugs.
FDA releases its 2022 report on advancing regulatory science with updates to the focus areas identified in the 2021 regulatory science report.
FDA accepts for review a Bausch & Lomb and Novaliq NDA for NOV03 (perfluorohexyloctane), an eye drop therapy for treating the signs and symptoms of dr...
