The Committee For Medicinal Products For Human Use (CHMP) Reaffirms Positive Opinion For Lecanemab In Early Alzheimer's Disease
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...
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The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease
Viehbacher, "Biogen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti ...
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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 ...
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KRYS Gets Positive CHMP Opinion for EU Approval of Skin Disease Drug
Krystal Biotech receives positive CHMP opinion recommending the approval of Vyjuvek for treating dystrophic epidermolysis bullosa in the EU.
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Eli Lilly’s Jaypirca recommended by CHMP to treat chronic lymphocytic leukaemia
Eli Lilly’s Jaypirca (pirtobrutinib) has been recommended by the European Medicines Agency’s (EMA) human medicines committee ...
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Regeneron receives positive CHMP opinion for linvoseltamab in multiple myeloma
Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency’s human medicines committee for ...
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Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug
The CHMP recommends conditional marketing authorization of REGN's linvoseltamab to treat adults with relapsed and refractory multiple myeloma.
Novartis Gets CHMP Opinion for Label Expansion of Fabhalta
The CHMP recommends granting a marketing authorization to NVS' Fabhalta for the treatment of adults with C3 glomerulopathy, an ultra-rare, progressive kidney disease with no currently approved ...
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Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...
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UK MHRA accepts Bavarian Nordic’s MAA for chikungunya vaccine, CHIKV VLP for persons aged 12 and older
Copenhagen, Denmark Monday, March 10, 2025, 11:00 Hrs [IST] ...