The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...

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

specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Last year we wrote a three-part series, "Life in the Fast ...

(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) Tuesday, announced the submission of a Marketing Authorization Application or MAA to the European Medicines Agency ... is already approved in the ...

Merck on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers the 21-valent conjugate vaccine for immunization for the prevention ...

SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency ...

UPDATED: Wednesday, Feb. 5 at 9:05 a.m. ET Novartis' Kisqali has secured a label expansion from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). The new approval covers ...

The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.

has submitted a marketing authorisation application to the European Medicines Agency for trofinetide for the treatment of Rett syndrome in adults and paediatric patients two years of age and older.