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A Health Affairs article discusses clarifications and revisions that it says are needed in an FDA draft guidance describing a plau...[ Price : $8.95]
Three Akin Gump attorneys highlight some changes in a 2026 FDA draft guidance on communicating healthcare economic information fro...[ Price : $8.95]
FDA extends the comment period by 30 days for its request for information on drug repurposing for unmet medical needs.[ Price : $8.95]
FDA approves an expanded dosing regimen for Lillys atopic dermatitis treatment Ebglyss (lebrikizumab-lbkz), allowing certain patie...[ Price : $8.95]
FDA sends an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and...[ Price : $8.95]
Gilead and Merck say they have discontinued the KEYNOTE-D46/EVOKE-03 study of Gileads Trodelvy and Mercks Keytruda as a treatment ...[ Price : $8.95]
FDA warns Indias Zydus Lifesciences Limited about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Chinas Hubei Gedian Humanwell Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceu...