News

Zacks Investment Research on MSN18d
EMA Accepts GSK's Filing for Expanded Use of Nucala in COPD
GSK plc GSK announced that the European Medicines Agency (“EMA”) has accepted for review a regulatory filing, seeking approval for a new indication of its respiratory drug, Nucala (mepolizumab). The ...
Medscape14d
Alzheimer Drug Donanemab Gets No-Go From European Regulator
The EMA has recommended refusing marketing authorization for donanemab, a monoclonal antibody against amyloid beta, in the ...
Pharmaceutical Technology on MSN17d
EMA to review GSK’s Nucala for COPD treatment expansion
The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on maintenance for individuals with chronic obstructive pulmonary disease ...
precisionmedicineonline14d
EMA's CHMP Recommends Against Approval of Eli Lilly's Alzheimer's Drug Kisunla in Europe
Lilly markets the monoclonal antibody in the US, Japan, China, and other countries for slowing Alzheimer's disease progression by removing beta-amyloid plaque. However, the CHMP determined that the ...
Pharmabiz17d
EMA accepts for review GSK’s application to expand use of Nucala for COPD treatment
EMA accepts for review GSK’s application to expand use of Nucala for COPD treatment: London, UK Wednesday, March 26, 2025, 11:00 Hrs [IST] GSK plc announced that the European Me ...
Yahoo Finance17d
EMA to review GSK’s Nucala for COPD treatment expansion
The European Medicines Agency (EMA) has agreed to review GSK’s ... If approved, the monoclonal antibody is expected to become the initial monthly-dosed biologic for COPD. GSK’s application ...