EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s mNEXSPIKE (COVID-19 Vaccine, mRNA)

NEXSPIKE is Moderna’s third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...
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MRK gets positive CHMP opinion for expanded use of Winrevair in PAH

Merck MRK announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending approval of an expanded indication for its ...
Morningstar

The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate ...
Medical Dialogues

Lupin receives positive EMA comittee opinion for eye therapy Ranluspec

Mumbai: Global pharma major Lupin Limited has announced that the Committee for Medicinal Products for Human Use (CHMP) of the ...

Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Final Decision from European Commission Expected in Q1 2026SOUTH SAN FRANCISCO, Calif., (GLOBE NEWSWIRE) -- Cytokinetics, ...

European Medicines Agency Committee Recommends Authorization of New Moderna Covid-19 Vaccine

Moderna on Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the marketing authorization of mNexspike, a new Covid-19 vaccine. The committee's ...
The Caledonian-Record

Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the ...
Nasdaq

The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU

STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the ...
Seeking Alpha

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 LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision "The CHMP's positive opinion on our updated ...
Morningstar

The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU | Morningstar

STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the ...
Seeking Alpha

Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer's disease

The opinion will now be referred to the European Commission for final regulatory decision on donanemab INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and Company (LLY) announced today that the ...