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...
FDA places a clinical hold on Quantum BioPharmas IND for its multiple sclerosis drug candidate Lucid-21-302.
Eight Mintz attorneys analyze the recent Supreme Court decision giving generic drug manufacturers a victory in an induced infringement case.
