European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
Pharmaceutical Technology1h
EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
The EMA’s Committee for Medicinal Products for Human Use has issued a positive recommendation for Eisai and Biogen’s Leqembi ...
CHMP issues positive recommendation for approval of lecanemab in the EU
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai ...
Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myelomaRecommendation based on IMROZ ...
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
precisionmedicineonline3h
EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.
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Novartis Gets CHMP Recommendation for Kisqali in Broader Population
Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA ...
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Apellis Stock Down as Eye Drug Faces Third CHMP Rejection in the EU
Apellis Pharmaceuticals APLS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European ...
Intercept loses Ocaliva FDA full approval bid in rare liver disease
Intercept’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...
FiercePharma17d
Astellas doesn't see eye to eye with Europe on geographic atrophy drug Izervay
Four months after the Committee for Medicinal Products for Human Use (CHMP) rejected Apellis’ GA application for Syfovre for a second time, Astellas has withdrawn its application for the ...
Arcturus Therapeutics: Overcoming Challenges and Poised for European Expansion
Arcturus Therapeutics Holdings, Inc. engages in the development of RNA therapeutics for treatment. It focuses on liver and respiratory diseases. Its pipeline include LUNAR-OTC, and LUNAR CF. The ...
BioArctic: CHMP issues positive recommendation for approval of lecanemab in the EU
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive ...