Drug Approvals
🇺🇸 FDA Page 46FDA news and analysis for pharmaceutical BD, investment, and market access · 12 articles on this page
Track global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.
Showing 541–552 of 665 articles
Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11
2 min
Daniel BrooksDupixent Becomes First Biologic Approved for Children Ages 2-11 with Chronic Spontaneous Urticaria
2 min
Dr. Sarah MitchellFDA Approval Elarekig: What You Need to Know About TRD Treatment
FDA · treatment-resistant depression · 10 min
Isabella CruzDenali Therapeutics Receives FDA Approval for Avlayah (Tividenofusp Alfa) to Treat Hunter Syndrome
Hunter syndrome (MPS II) · 3 min
Michael RiveraFDA Extends Sanofi Sarclisa Subcutaneous Review by Three Months for Multiple Myeloma Treatment
2 min
Dr. Priya NandakumarNRx Pharmaceuticals Receives Positive FDA Feedback on Preservative-Free Ketamine Generic Drug Application
FDA · 3 min
Daniel BrooksLupin Launches Generic Dapagliflozin-Metformin XR Tablets in US as Xigduo XR Alternative
2 min
Dr. Laura BennettSanofi's Tzield Approved by FDA for Children as Young as 1 Year to Delay Type 1 Diabetes Progression
Type 1 Diabetes · 3 min
Dr. Priya NandakumarGeneric Drug Forum: Key Takeaways for US Market Access
general · 12 min
Dr. Sarah MitchellTHMA CPE Circle 2026: Pharma Exec Networking Focus
general · 3 min
Dr. Sarah MitchellFDA Approves Merck's IDVYNSO: First Non-INSTI, Tenofovir-Free Two-Drug HIV Treatment
FDA · HIV Treatment · 3 min
James Chen, PharmDFDA Approval of Viruxa: Market Analysis and Clinical Review for Advanced Melanoma
FDA · Advanced Melanoma · 8 min
Prof. Marcus WebbExplore intelligence