GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recent Phase 1-2 study.
FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.
FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.
FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthalmic solutions.
Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation about prescription drugs...
FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.
Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority review voucher.
CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to learn about inspection ...
