FDA approves an Amag Pharmaceuticals NDA for Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal...
Federal Register notice: FDA submits to OMB an information collection extension entitled Reporting Associated With New Animal Drug Applications (NADA)...
Federal Register notice: FDA posts a final guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Lab...
Federal Register notice: FDA schedules Allergenic Products Advisory Committee meeting to review Peanut [Arachis hypogaea] Allergen Powder manufactured...
Several U.S. House democrats introduce HR 3379, the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act, that would reduce the ...
FDA lifts a partial clinical hold on an AbbVie/Genentech Phase 3 CANOVA (M13-494) trial evaluating venetoclax for the investigational treatment of rel...
FDA issues a five-page Form 483 after it inspected a Sun Pharmaceutical Industries Gujarat, India manufacturing facility 6/3-11.
An FDA Advisory Committee unanimously agrees that data show a mortality signal associated with paclitaxel-coated products, but they were uncertain as ...