FDA warns Dabur India Limited about CGMP violations in its production of finished drugs.
FDA warns St. Louis, MO-based Koven Technologies about QSMR issues in its manufacturing and marketing of the Bidop 3 Doppler.
FDA warns Germanys Thomas Brunner Hygiene about CGMP and other violations in its production of unapproved and misbranded antiperspirants.
Jazz Pharma says it will seek FDA approval to remove Zepzelcas (lurbinectedin) second-line metastatic small cell lung cancer indication based on data...
FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance...
FDA undertakes a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance on remote evaluation ...
FDA issues an updated final guidance entitled Applying Human Factors and Usability Engineering to Medical Devices.
FDA grants Eli Lilly a breakthrough therapy designation for olomorasib as a monotherapy for treating adult patients with advanced pancreatic cancer.
