FDA and Tonix Pharmaceuticals align on the protocol for an adaptive Phase 2 study of the companys TNX-4800 to prevent Lyme disease.
An FDA inspection cites multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturing facility in Ahmed...
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...
