EMA rethinks stance, committee now recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
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 ...
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.
Zacks.com on MSN24d
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 ...
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Medicinal Products for Human Use (CHMP) rejected Apellis’ GA application for Syfovre for a second time, Astellas has withdrawn its application for the ...
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 ...
Hosted on MSN7mon
EMA CHMP recommends Novo Nordisk’s weekly insulin for diabetes
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Novo Nordisk's Awiqli, a once-weekly basal insulin icodec, for ...
BioWorld24d
CHMP nods for Korjuny, Alhemo; no, again, for Translarna, masitinib
Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for ...
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 ...