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EU Regulators Back First Combined COVID-19 and Flu mRNA Shot for Adults 50 and Over

A European Commission decision now determines EU authorization, after which Member States will set pricing and rollout.

EMA Panel Backs Conditional EU Approval for Ojemda in Pediatric Low-Grade Glioma

FDA Approves Dupixent as First Treatment for Allergic Fungal Rhinosinusitis

FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

NICE Recommends First Vitiligo Repigmentation Cream for NHS Use in England

FDA Approves Vanda’s Bysanti for Bipolar I Mania and Schizophrenia

FDA Approves First All-Oral, Fixed-Duration First-Line CLL/SLL Regimen: Calquence Plus Venetoclax

FDA Sets Single-Study Default for New Drug Approvals

EU Grants Conditional Approval for ImmunityBio’s Anktiva in BCG‑Unresponsive Bladder Cancer

AppLovin Jumps After CapitalWatch Walkback as Jefferies Reaffirms Bullish Call

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

FDA Grants Priority Review to Leqembi Autoinjector for Weekly At-Home Starting Dose

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

NEJM Publishes Phase 3 Data Showing Ajovy Reduces Pediatric Migraine Days

FDA Approves Zycubo, First U.S. Treatment for Menkes Disease

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

FDA Issues Complete Response Letter for Corcept’s Relacorilant in Cushing’s-Related Hypertension

FDA Approves First Oral GLP-1 for Obesity as Novo’s Wegovy Pill Sets January U.S. Launch

FDA Approves Aqvesme for Thalassemia Anemia, First U.S. Therapy for Both Patient Groups