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 ...
The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
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 European Medicines Agency has reaffirmed its ...
BioArctic: The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) ...
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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Rare diseases: CHMP recommends Krystal’s Vyjuvek for dystrophic epidermolysis bullosa
The European Medicines Agency’s (EMA) human medicines committee has recommended Krystal Biotech’s Vyjuvek (beremagene ...
Daily19h
Novartis oral Fabhalta receives positive EMA Committee opinion for adults with C3 glomerulopathy
Basel: Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
Valneva reports positive CHMP opinion for adolescent label extension for Ixchiq
Valneva (VALN) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive ...
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...
Krystal gets positive EU regulatory opinion for Vyjuvek
Krystal Biotech (KRYS) has received a positive recommendation from EU regulators for its drug Vyjuvek for the treatment of ...
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EMA committee recommends marketing approval for Novartis oral Fabhalta to treat adults living with C3 glomerulopathy
EMA committee recommends marketing approval for Novartis oral Fabhalta to treat adults living with C3 glomerulopathy: Basel Monday, March 3, 2025, 10:00 Hrs [IST] Novartis announc ...
Pharmabiz15h
EMA committee recommends approval of AbbVie’s upadacitinib to treat adults with giant cell arteritis
EMA committee recommends approval of AbbVie’s upadacitinib to treat adults with giant cell arteritis: North Chicago, Illinois Monday, March 3, 2025, 15:00 Hrs [IST] AbbVie annou ...
Krystal Biotech Gets CHMP Backing for Vyjuvek Approval
Krystal Biotech said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of its Vyjuvek topical gene therapy for certain patients with the rare ...