FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.
A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.
FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug experience reporting...
FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.
FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equinoxe Reverse Shoulder...
FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.
FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.
FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.
