Three Akin Gump attorneys highlight some changes in a 2026 FDA draft guidance on communicating healthcare economic information from its 2018 final gui...
FDA extends the comment period by 30 days for its request for information on drug repurposing for unmet medical needs.
FDA approves an expanded dosing regimen for Lillys atopic dermatitis treatment Ebglyss (lebrikizumab-lbkz), allowing certain patients with moderate-to...
FDA sends an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and quality oversight a...
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...
