FDA News

FDA Clears First OTC CGM for Children: Dexcom Expands Stelo

FDA · diabetes · 4 min

FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC

FDA · adjuvant renal cell carcinoma · 6 min

FDA adds bemotrizinol to sunscreen rules, expanding U.S. UV filter options

FDA · sunburn · 5 min

FDA approves Vepdegestrant (Veppanu) for ESR1-mutated breast cancer

FDA · estrogen receptor-positive, HER2-negative breast cancer · 6 min

Sensorion pivots to SENS-601 after Regeneron’s OTOF hearing loss advance

FDA · hearing loss · 4 min

FDA Issues Guidance on Human Factors Information in Marketing Submissions

FDA · 5 min

FDA authorizes generic nitenpyram for New World screwworm in pets

FDA · New World screwworm · 5 min

FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria

FDA · rheumatoid arthritis · 6 min

AstraZeneca expands obesity push as it invests $125M in ultrasound medicine

FDA · obesity · 5 min

FDA Drug Approval: What Approval Means for Pharma Marketing and BD

FDA · 5 min

FDA investigates Salmonella in moringa leaf powder, expands recall

FDA · Salmonella · 4 min

Vanda tradipitant update: FDA re-review extends to Dec. 5, 2025

FDA · 6 min