FDA News

CAR-T Therapy Clinical Trials: Insights from ASCO 2026 and FDA Approval Implications

FDA · Oncology · 11 min

Biosimilars Market Analysis: Impact of Recent FDA Approvals on US Pricing & Competition

FDA · Oncology · 10 min

FDA Accelerated Approval Pathway: Impact on Oncology Drug Development & Market Access 2026

FDA · oncology · 9 min

Inflation Reduction Act Drug Pricing: Impact on FDA Negotiations & Innovation 2026

FDA · Pharmaceutical Market · 9 min

FDA Companion Diagnostic Policies: Market Evolution in Precision Oncology

FDA · oncology · 10 min

Biosimilars Market Analysis: US Landscape Post-Inflation Reduction Act 2026

FDA · biosimilars · 8 min

FDA Accelerated Approvals Oncology: 2026 Review of Benefit-Risk and Confirmatory Trials

FDA · Oncology · 10 min

FDA Biosimilar Approval Pathway: Key Regulatory Changes & Market Impact 2026

FDA · biosimilars · 9 min

SURPASS-CVOT Trial Results: Implications for Mounjaro's Cardiovascular Safety and FDA Labeling

FDA · Type 2 Diabetes · 6 min

FDA Approves Johnson & Johnson's CAPLYTA (Lumateperone) sNDA for Schizophrenia Relapse Prevention

FDA · 2 min

Pembrolizumab FDA Approval: Expanded Use for MSI-High Solid Tumors

FDA · Oncology · 5 min

GLP-1 Eating Disorder Risk: What You Need to Know

FDA · Obesity and type 2 diabetes · 4 min