The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25 ...

Kisunla’s active substance is donanemab, a monoclonal antibody that targets and clears amyloid-beta plaques in the brain, a ...

The opinion is based on positive data from the phase 3 Balance study, which showed a significant reduction of triglycerides ...

Moderna (MRNA) nnounced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for an updated ...

"Gilead wins positive European approval opinion for twice-yearly HIV injection" was originally created and published by ...

--BioArctic AB's partner Eisai today announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ ...

BeiGene's Tevimbra gets a highly sought after recommendation. The oncology company said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive ...

TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025/ PRNewswire/-- Eisai Co., Ltd. and Biogen Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency ...

EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Marketing Authorization Of Moderna’s RSV Vaccine, mRESVIA (R) ACCESSWIRE Updated June 28, 2024 4:15 AM ...

Press Releases EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s COVID-19 mRNA Vaccine Targeting the SARS-COV-2 Variant JN.1 ...

The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU Provided by PR Newswire Feb 28, 2025 5:11am ...