The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

The Committee for Medicinal Products for Human Use recommends approval for Merck's pneumococcal 21-valent conjugate vaccine, ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...

Despite the regulatory setback, BioArctic's partner Eisai has stated that the safety profile of lecanemab reported in clinical practice in the United States, Japan, and other countries is consistent ...

Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...

Biogen (BIIB) and Eisai announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as ...

Valneva's Ixchiq vaccine – which was cleared in the EU, the US, and Canada last year – is currently indicated for preventing ...

Eisai and Biogen update on lecanemab's EU regulatory review for early Alzheimer’s disease treatment following positive CHMP opinion. Eisai Co., Ltd. and Biogen Inc. have provided an update on ...

AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the European Commission has asked the Committee for Medicinal Products for Human Use (CHMP) to consider two ...

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...