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FDA Approvals

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FDA Expands Casgevy Gene Therapy to Children Ages Two and Up

Earlier treatment could reduce lasting organ damage, requiring regulators and clinicians to monitor long-term safety, durability and access.

Moderna Restructures Leadership as It Prepares for Multiple Vaccine Launches

FDA Clears Dexcom Stelo Over‑the‑Counter Glucose Monitor for Children Ages 2 and Up

FDA Grants Accelerated Approval to Sanofi’s Tzield for Children With Stage 3 Type 1 Diabetes

GSK to Buy Nuvalent for $10.6 Billion to Bolster Lung‑Cancer Pipeline

Sun Pharma Accelerates Shift to Specialty Drugs With $11.75 Billion Organon Purchase

FDA Approves Datroway as First‑Line Option for Immunotherapy‑Ineligible Triple‑Negative Breast Cancer

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

FDA Approves Langlara as Interchangeable Biosimilar to Lantus

Regeneron Tops Q1 Estimates as Dupixent and Libtayo Outpace Eylea

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

SCYNEXIS Acquires Poxel’s PXL-770 for ADPKD, Plans 2026 Phase 2 Trial

FDA Clears Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

Taysha Advances Rett Gene Therapy Program With Pivotal Dosing, FDA Alignment and Q2 Data Timeline

FDA Clears J&J’s Icotyde, First Oral IL-23 Psoriasis Therapy for Ages 12 and Up

Iovance Shares Hit Record After UBS Doubles Price Target

Lilly Launches FDA-Cleared Monthly Zepbound KwikPen on LillyDirect at $299 Starter Price

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression