Gilead Sciences has announced EMA validation for a parallel accelerated review of lenacapavir’s MAA and EU-M4all applications ...
With the European Medicines Agency identifying shortages in more than 30 critical medicines, the single market presents an opportunity to rethink ...
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social media platform that some have ...
New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...
| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...
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 ...
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 ...
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 ...