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Drug Approval

FDA FDA Approval FDA Regulations Alzheimer's Disease Lecanemab FDA Approvals Alzheimer's Treatment Cancer Treatment Regulatory Agencies Clinical Trials

FDA Approves First Therapy for Acquired Hypothalamic Obesity, Expanding Rhythm’s Imcivree

The decision follows a late-stage study that showed a 15.8% BMI reduction at 52 weeks compared with a 2.6% increase on placebo.

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

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy

MHRA Approves Leqselvi for Severe Alopecia Areata in Adults

FDA Approves Leucovorin for Ultra-Rare FOLR1 Folate Disorder, Declines Autism Indication

FDA Approves Sotyktu for Active Psoriatic Arthritis as First TYK2 Inhibitor

FDA Biologics Chief Vinay Prasad to Step Down at End of April

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

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

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

Spain Halves Time to Fund Innovative Medicines, Health Ministry Reports

AppLovin Jumps After CapitalWatch Walkback as Jefferies Reaffirms Bullish Call

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

Anvisa Expands Wegovy and Ozempic Uses to Cardiovascular and Kidney Protection

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