FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when used in combination wi...
An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (delandistrogene moxeparvov...
An online post details a significant number of resignations from CDER in the first six months of this year.
FDA issues an alert saying B. Braun Medical has notified customers recommending that certain microbore extension sets be removed from the market becau...
FDA grants priority review to Johnson & Johnsons NDA for TAR-200 for treating patients with Bacillus Calmette-Gurin-unresponsive high-risk non-muscle ...
A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments is not supported by ...
FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding Project Orbis from ...
Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial intelligence tool and ap...
