Abeona Therapeutics plans to file a BLA for EB-101, a cell therapy for patients with recessive dystrophic epidermolysis bullosa, after a pre-BLA meeti...
FDA grants Quest Diagnostics a breakthrough device designation for its AAVrh74 ELISA assay for identifying Duchenne muscular dystrophy patients eligib...
Reagan-Udall Foundation director of research Carla Rodriguez explains the RAISE program that is helping to collect, curate, and integrate race and eth...
FDA warns Pomona, CA-based K.C. Pharmaceuticals about CGMP violations in its production of finished drugs.
FDA warns Miami, FL-based Gadal Laboratories about CGMP violations in its production of finished drugs.
FDA warns Milford, DE-based Tesla BioHealing about illegally marketing adulterated and misbranded medical devices.
Janssen Pharmaceutical files a supplemental NDA that is seeking to convert Balversas (erdafitinib) 2019 accelerated approval to full approval for trea...
FDA approves a Bristol Myers Squibb BLA supplement for Reblozyl (luspatercept-aamt) for treating anemia in patients with very low- to intermediate-ris...
