Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its 21-valent pneumococcal conjugate ...

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...

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

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 ...

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 ...

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

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 ...

These will be discussed at the CHMP meeting in February 2025 ... Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties ...

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

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 ...

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

These questions will now be discussed at the CHMP meeting in February 2025, before the Commission can take a final decision on the Marketing Authorization Application for lecanemab as treatment ...