FDA agrees to accept a CytoDyn rolling BLA submission for PRO 140 (leronlimab), a CCR5 antagonist, indicated for blocking HIV-1 from entering and infe...
Federal Register notice: FDA submits to OMB an information collection extension for Financial Disclosure by Clinical Investigators.
FDA clears a Safe Medical Design 510(k) for the Signal Catheter, a urinary catheter that is designed to reduce urethral trauma caused by premature bal...
FDA Review has posted the Federal Register notices for the week ending 3/1/2019.
FDA Review posts product approval summaries for the week ending 3/1/2019.
FDA issues a final guidance on Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and C...
Federal Register notice: FDA seeks comments on World Health Organization recommendations to impose international manufacturing and distributing restri...
The FTC reaches a settlement in FTC v. Actavis, a 2009 case alleging that Solvay and three generic drug companies illegally agreed to restrict generic...