CHMP will dig into the new info during a meeting ... The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Winrevair in combination with other PAH therapies to improve ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

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 ...

The European Commission (EC) has already approved Valneva’s chikungunya vaccine Ixchiq for use in individuals aged 18 years ...

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 ...

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 ...

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 ...

Additionally, the CHMP will review the clarity of risk minimization ... with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and ...

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