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

It also means that most regulatory watchers may not be looking at the appropriate endpoint for calculating and comparing relative cycle times. In most cases, the EC agrees with the CHMP's ...

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

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to ...

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 ...

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

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 ...

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 ...

These will be discussed at the CHMP meeting in February 2025 ... Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co ...