The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: ...
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) ...
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 ...
PMLive3d
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 ...
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 ...
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 ...
Medical Dialogues7d
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 ...
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 ...
TMCnet9d
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 ...
PMLive6d
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 ...
Regeneron Pharmaceuticals, Inc.: Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human ...