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Drug Approvals

🇺🇸 FDA Page 46

FDA 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

Critical impact NewsApr 23, 2026

Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11

2 min

Daniel Brooks
Critical impact NewsApr 23, 2026

Dupixent Becomes First Biologic Approved for Children Ages 2-11 with Chronic Spontaneous Urticaria

2 min

Dr. Sarah Mitchell
High impact AnalysisApr 23, 2026

FDA Approval Elarekig: What You Need to Know About TRD Treatment

FDA · treatment-resistant depression · 10 min

Isabella Cruz
Critical impact NewsApr 22, 2026

Denali Therapeutics Receives FDA Approval for Avlayah (Tividenofusp Alfa) to Treat Hunter Syndrome

Hunter syndrome (MPS II) · 3 min

Michael Rivera
High impact NewsApr 22, 2026

FDA Extends Sanofi Sarclisa Subcutaneous Review by Three Months for Multiple Myeloma Treatment

2 min

Dr. Priya Nandakumar
High impact NewsApr 22, 2026

NRx Pharmaceuticals Receives Positive FDA Feedback on Preservative-Free Ketamine Generic Drug Application

FDA · 3 min

Daniel Brooks
High impact NewsApr 22, 2026

Lupin Launches Generic Dapagliflozin-Metformin XR Tablets in US as Xigduo XR Alternative

2 min

Dr. Laura Bennett
Critical impact NewsApr 22, 2026

Sanofi'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 Nandakumar
Critical impact NewsApr 22, 2026

Generic Drug Forum: Key Takeaways for US Market Access

general · 12 min

Dr. Sarah Mitchell
Critical impact NewsApr 22, 2026

THMA CPE Circle 2026: Pharma Exec Networking Focus

general · 3 min

Dr. Sarah Mitchell
Critical impact NewsApr 22, 2026

FDA Approves Merck's IDVYNSO: First Non-INSTI, Tenofovir-Free Two-Drug HIV Treatment

FDA · HIV Treatment · 3 min

James Chen, PharmD
High impact AnalysisApr 22, 2026

FDA Approval of Viruxa: Market Analysis and Clinical Review for Advanced Melanoma

FDA · Advanced Melanoma · 8 min

Prof. Marcus Webb