Health ❯ Healthcare ❯ Regulatory Affairs

Marketing Authorization

European Medicines Agency Conditional Marketing Authorization Eli Lilly Nederland B. V. EMA PRIME Scheme Exceptional Circumstances

CHMP Backs Xolremdi for WHIM Syndrome Under Exceptional Circumstances

A European Commission decision now follows, reflecting limited trial data in a rare disease that require ongoing evidence commitments.

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