FDA News

BIO 2026 Preview: Companies to Watch and Key Catalysts

FDA · 4 min

FDA Approves Incyte's Jakafi XR Extended-Release Tablets for Myelofibrosis and Blood Disorders

FDA · Hematology/Oncology · 3 min

Arvinas VEPPANU (Vepdegestrant) Receives FDA Approval as First PROTAC Drug for ESR1-Mutated Breast Cancer

FDA · Oncology - Advanced Breast Cancer · 3 min

Auvelity FDA Approval: New MDD Treatment Option

FDA · Major Depressive Disorder (MDD) · 12 min

FDA Scrutiny Post-Market Data: Impact on Pharma Investment Strategies

FDA · 7 min

FDA Accelerated Approval Pathway: Impact on Oncology Market Access & Pricing in 2026

FDA · oncology · 9 min

FDA Guidance on Oncology Drugs: New Rules for Accelerated Approval

FDA · Oncology · 9 min

Arvinas Receives FDA Approval for VEPPANU (Vepdegestrant), First PROTAC Drug for ESR1-Mutated Breast Cancer

FDA · Oncology - Breast Cancer · 3 min

Mounjaro FDA Approval Obesity: Eli Lilly's Tirzepatide Awaits

FDA · obesity, cardiovascular outcomes · 13 min

Osimertinib FDA Approval Expands Early-Stage NSCLC Treatment

FDA · early-stage non-small cell lung cancer (NSCLC) adjuvant therapy · 6 min

FDA Approval OncoBlast: Market Impact for Advanced Melanoma

FDA · Oncology · 5 min

KRAS G12C Inhibitors NSCLC: Market Analysis of Sotorasib & Adagrasib

FDA · oncology · 9 min