FDA approves Takedas Orzeyful as the first drug to treat all symptoms of narcolepsy type 1 in adults.
Fresenius Kabi recalls one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a labeling mix-up that coul...
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 issues an early alert warning healthcare providers not to use certain Becton Dickinson intraosseous vascular access needle sets after the company ...