Pathways to success for this key component of Europe’s new HTA regulation, where thinking beyond the purely technical will be ...

ANDEMBRY®, the first and only once-monthly treatment targeting factor XIIa to prevent attacks in HAE patients, inhibits plasma protein factor ...

Galapagos is dropping its junior CD19 CAR-T as part of the Belgian biotech’s seemingly never-ending mission to recalibrate ...

Anavex Life Sciences Corp. expects feedback from the European Medicines Agency on blarcamesine for Alzheimer's Disease this ...

The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

The approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in ...

Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

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

This acquisition was linked to the European Medicines Agency's acceptance of a Marketing Authorization Application for mavorixafor, a treatment for WHIM syndrome. Following these transactions ...

If successful, the results of the trials may support applications to the Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulatory bodies for approval for use in refractory ...

AMSTERDAM, Jan 27 (Reuters) - 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 ...