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 ...

This delay, attributed to procedural issues at the European Medicines Agency (EMA), has implications ... Reuters noted that an approval is expected in the second half of 2024, versus Eisai ...

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

Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...

ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ... s approval for subcutaneous use ...

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

The US-developed NOVAVAX vaccine against COVID-19 has been approved Monday by the European Medicines Agency (EMA), thus becoming the fifth drug of its kind to become available at a continental level.

(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 ...