Health ❯ Healthcare ❯ Regulatory Affairs

Marketing Authorization

European Medicines Agency Conditional Marketing Authorization Pediatric Use Marketing Authorization (PUMA) Exceptional Circumstances Eli Lilly Nederland B. V. EMA PRIME Scheme

EU Drug Panel Backs Imdylltra for Relapsed Small Cell Lung Cancer

Phase 3 results showing longer survival now trigger a final review by the European Commission.

CHMP Backs Xolremdi for WHIM Syndrome Under Exceptional Circumstances

CHMP Backs Expanded EU Use of Mounjaro for Diabetes in Patients 10+ and Adult Weight Management

EU Medicines Panel Backs Teizeild to Delay Type 1 Diabetes Onset

EU Regulators Back Uplizna as First Treatment for IgG4‑Related Disease

CHMP Backs Subcutaneous Lunsumio for Relapsed Follicular Lymphoma