The Latest Breaking News from EMA

In the development of regulated medical devices, adherence to stringent regulatory requirements is not optional but a foundational necessity. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others around the world enforce strict guidelines to ensure the safety, efficacy, and reliability…

After years of winter medicine shortages, the European Medicines Agency told Euronews that there are currently no signs of antibiotic shortages, amid EU efforts to reduce dependency on foreign suppliers.

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD).

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Friday recommending Eli Lilly and Co.’s (NYSE:LLY) donanemab for early symptomatic Alzheimer’s disease in adults with confirmed amyloid pathology who are apolipoprotein E ε4 (ApoE4) heterozygotes or non-carriers.

Inhalers may be small, but they can make a big impact on the environment.

An expert committee recommended that the drug be offered to a narrow group of patients with early-stage Alzheimer’s disease.

The drug is expected to be formally approved by the European Commission this year.

Manthey Porsche driver Thomas Preining clinched victory in the second DTM race of the Norisring round.

Manthey Porsche driver Thomas Preining clinched victory in the second race of the Norisring round in the 2025 DTM season.