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, ...

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

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

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

The CHMP of the European Medicines Agency based ... The company noted that regulatory applications are currently under review in Japan and several other countries in this indication.

Pioneering license agreement with BrainTransporter signed with BMS worth up to USD 1.35 billion plus royalties Events during the fourth quarter 2024 The Australian Medicines Agency (TGA) decided not ...

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 ...