But it remains far smaller than its rivals. EMA is a decentralised agency of the EU, responsible for the scientific evaluation, supervision and safety monitoring of medicines. Its headquarters are ...
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Hosted on MSNEU reshapes HTAs: is the industry ready for it?New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
The EMA followed suit and approved the vaccine in the EU in July 2024. Valneva has since applied to extend Ixchiq’s approval to adolescents in both the EU and US. Meanwhile, Bavarian Nordic’s vaccine ...
DIA's Europe Annual Meeting, featuring discussions from top European health leaders, will be held March 18-20 in Basel.
The EMA is implementing major changes to accelerate drug approvals in the EU, addressing delays that affect patients and businesses alike. Following a turbulent period marked by Brexit and the ...
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) ...
In the latest development, the European Commission has asked the EMA's human medicines committee ... but it does represent a delay to Leqembi's EU approval, which was expected within the usual ...
In its first meeting of 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the green light for the first vaccine in the EU to protect adolescents ...
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee ...
5 In its first Bluesky post (@ema-eu.bsky.social) EMA used it as an opportunity to re-introduce the agency’s goals and what it does for public and animal health with a short video. 6 Responses were ...
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