Drug Approvals News
🇺🇸 FDAFDA breaking news and regulatory updates for BD, investors, and analysts
Showing 1–12 of 338 articles
Adial Pharmaceuticals Completes Azora Merger, Expands Ulcerative Colitis Pipeline
FDA · 3 min
Michael RiveraFDA approves OTC Rextovy, broadening naloxone access for opioid overdose
FDA · opioid overdose · 6 min
Dr. Sarah MitchellLilly’s early JAK data raises myelofibrosis competition question
FDA · myelofibrosis · 6 min
Dr. Sarah MitchellFDA authorizes emergency pet treatment for New World screwworm
FDA · New World screwworm · 4 min
Dr. Sarah MitchellFDA guidance on sharing potential NDA patent information: what changes now
FDA · 4 min
Dr. Sarah MitchellFDA expands Tzield to certain pediatric patients with recent Stage 3 T1D
FDA · diabetes · 5 min
Dr. Sarah MitchellMedicare price rule could hit Keytruda and Opdivo subcutaneous launches
Medicare · cancer · 5 min
Dr. Sarah MitchellFDA Approves Capivasertib for PTEN-Deficient Prostate Cancer
FDA · prostate cancer · 6 min
Dr. Sarah MitchellFDA approves belzutifan plus pembrolizumab for adjuvant RCC
FDA · renal cell carcinoma · 6 min
Dr. Sarah MitchellPrescription Drug Freight Fraud June 2026 report: what the record shows
EMA · 5 min
Dr. Sarah MitchellAlembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules
FDA · NTRK fusion–positive solid tumors · 7 min
Dr. Sarah MitchellFDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC
FDA · adjuvant renal cell carcinoma · 6 min
Dr. Sarah MitchellExplore intelligence