Gilead and Merck say they have discontinued the KEYNOTE-D46/EVOKE-03 study of Gileads Trodelvy and Mercks Keytruda as a treatment for certain patients...
FDA warns Indias Zydus Lifesciences Limited about CGMP violations in its manufacturing of finished drugs.
FDA warns Chinas Hubei Gedian Humanwell Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical ingredients.
FDA documents GMP issues at a long-troubled Bloomington, IN, fill-finish facility formerly owned by Catalent and acquired by Novo Nordisk in late 202...
Disc Medicine says it has reached agreement with FDA on a potential regulatory path forward for its investigational therapy bitopertin after receiving...
Senators Mike Lee (R-UT) and Tommy Tuberville (R-AL) introduce the Homeopathic Drug Product Safety, Quality, and Transparency Act.
Eli Lilly reports Phase 3 study results showing its oral GLP-1 receptor agonist Foundayo (orforglipron) outperformed Novo Nordisk's oral semaglutide o...
Delegates at the American Medical Association's annual meeting vote to support stronger FDA oversight of synthetic peptide products, citing growing co...
