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 ...

b. gambiense strain of the disease received a ‘positive opinion’ from the European Medicines Agency — a form of approval for drugs that will be used outside the European Union — and ...

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 ...

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

(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 ...

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 ...

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