Medscape1d
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 ...
EU regulators block new Alzheimer’s drug citing potentially fatal side effects
The company behind the drug donanemab said it will ask regulators to reconsider the decision. View on euronews ...
Pharmaceutical Technology on MSN4d
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 ...
pharmaphorum29d
EMA backs emergency use of Lilly’s COVID antibodies
The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member ...
precisionmedicineonline1d
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 ...
Pharmabiz3d
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 ...
Center for Biosimilars5d
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and ...
GSK application to expand use of Nucala to COPD accepted for review by EMA
GSK (GSK) plc announced that the European Medicines Agency has accepted for review its application to expand the use of Nucala, a monoclonal ...