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: ...
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 ...
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, ...
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 ...
Novartis announces CHMP of EMA adopted positive opinion for Fabhalta
Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a ...
Roche gets positive EU regulatory opinion for Columvi
Roche (OTCQX:RHHBY) said the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended ...
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CHMP Recommends Approval of Krystal Biotech's Gene Therapy Vyjuvek for Wound Skin Condition
Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.
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CHMP Recommends Vertex's Kaftrio, Kalydeco Combo for Additional Cystic Fibrosis Patients
The committee supports approving the CFTR modulator for patients 2 years and older with at least one non-class I CFTR gene mutation.
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 ...
Abbvie Receives Positive CHMP Opinion For Upadacitinib (RINVOQ®) For The Treatment Of Adults With Giant Cell Arteritis
The positive opinion is based on results from the pivotal Phase 3 SELECT-GCA trial that evaluated the efficacy and safety of upadacitinib ...
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 ...
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) ...