Business ❯ Pharmaceutical Industry

Drug Approval

FDA Regulations Regulatory Affairs FDA Market Analysis FDA Approval Market Introduction Investigational New Drug Regulatory Challenges Market Competition Cost Reduction Vaccine Development Market Potential Food and Drug Administration Novo Nordisk Market Impact European Medicines Agency Weight-Loss Treatment Market Trends Regulatory Agencies FDA Approvals

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.

Sanofi Pushes Amlitelimab Toward 2026 Filings After Mixed Phase 3 Readouts

FDA Approves Zycubo, First U.S. Treatment for Menkes Disease

FDA Grants Accelerated Approval to Subcutaneous Lunsumio for Relapsed Follicular Lymphoma

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

FDA Approves Breyanzi for Marginal Zone Lymphoma After Two or More Therapies

FDA Approves Novartis’ Itvisma for SMA Patients Ages 2 and Up

Bayer Stroke Drug Asundexian Hits Phase III Goals, Shares Jump

FDA Approves J&J’s Caplyta for Major Depressive Disorder

Datroway Extends Survival Over Chemotherapy in First-Line TNBC Ineligible for Immunotherapy

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