Business ❯ Pharmaceutical Industry ❯ Drug Approval

FDA Regulations

Market Impact Oral Medications Priority Review Voucher Market Launch Priority Review Novo Nordisk Vertex Pharmaceuticals

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

The one-time autologous treatment won conditional clearance on biomarker gains, requiring long‑term confirmation of benefit.

FDA Grants Priority Review for Enhertu Plus Pertuzumab in First-Line HER2-Positive Metastatic Breast Cancer