Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.
FDA warns Marietta, GA-based Cosco International about CGMP violations in its production of unapproved and misbranded drugs.
A group of bipartisan House lawmakers introduce the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deductions for the annual ...
FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeut...
FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic procedures.
FDA warns Brooksville, FL-based BEO Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
FDA approves Abeona Therapeutics Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene therapy for treating ...
Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a recent FDA Warning Letter to Exer Labs.
