First chikungunya vaccine approved in Europe for persons as young as 12 years old.On track for launch in key European markets ...

Krystal said it is on track to launch Vyjuvek in Germany in the middle of the year and in France later in 2025.

RESVIA® is Moderna's second approved product in the UK CAMBRIDGE, MA / ACCESS Newswire / February 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regu ...

The committee supports approving the CFTR modulator for patients 2 years and older with at least one non-class I CFTR gene mutation.

The treatment has gained approval in the European Union (EU) for a range of conditions, including psoriatic arthritis, ...

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

Novartis (NYSE:NVS) announced Friday that the European Medicines Agency (EMA), endorsed Fabhalta for the treatment of adults ...

Eli Lilly said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended expanded approval of its Jaypirca cancer drug in certain patients with chronic lymphocytic ...

Eli Lilly (LLY) and Company announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive ...

In December 2024, Praxis received Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA) for relutrigine for Dravet Syndrome. This is the third RPDD for relutrigine ...

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...