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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CHMP recommends AbbVie’s Rinvoq be approved for adult GCA
The treatment has gained approval in the European Union (EU) for a range of conditions, including psoriatic arthritis, ...
Pharmabiz1h
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 Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa
Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today welcomed the European Medicines Agency's (EMA’s) announcement that its Committee for Medicinal ...
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 ...
Pharmabiz6h
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 ...
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 ...
Krystal gets positive EU regulatory opinion for Vyjuvek
Krystal Biotech (NASDAQ:KRYS) has received a positive recommendation from the European Medicines Agency's Committee for ...
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
(NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing ...
Novartis oral Fabhalta® (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy (C3G)
If approved, Fabhalta® will be the only medicine indicated to selectively target the underlying cause of C3G1, an ultra-rare, progressive kidney disease with no currently approved treatments2-5 Phase ...
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) ...