FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.
FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Innovation Network.
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 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...
