FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when used in combination wi...
Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial intelligence tool and ap...
FDAs Oncologic Drugs Advisory Committee votes against approving GSKs BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma ...
Dexcom recalls certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert from sounding.
Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigation into what they sa...
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 ...
