FDA warns Condemned Labz that it is marketing misbranded unapproved new drugs.
PhRMA tells FDA it appreciates many of the revisions the agency has made to a draft guidance on sponsor responsibilities for safety assessment and rep...
FDA grants priority review to ViiVs cabotegravir to prevent acquisition of HIV in certain men.
The Justice Department says Affordable Healthcare Solutions pled guilty to one felony count of receiving adulterated medical devices in interstate com...
FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat certain patients with recurr...
Eisai begins a rolling BLA submission for lecanemab, the companys investigational anti-amyloid beta protofibril antibody for treating early Alzheimers...
Pfizer submits a clinical trial protocol amendment for a Phase 3 gene therapy trial for fordadistrogene movaparvovec in Duchenne Muscular Dystrophy pa...
Federal Register notice: FDA announces a 10/13-14 public workshop entitled Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients ...