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 ...

Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector

Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a ...
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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 ...
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 ...

European health regulator recommends approval for GSK's twice yearly asthma drug

Dec 12 () - The European Medicines Agency has ​recommended the approval ‌of GSK's add-on drug to ‌treat asthma and a chronic ...

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 ...

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, ...
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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 ...
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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 ...
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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 ...