The European drug authority recommends refusal of marketing authorization due to evidence gaps in quality and efficacy.

The drug failed to meet its primary endpoints in clinical trials, but subgroup analyses hinted at modest benefits.

The EU's medicines regulator said it would approve the treatment for a limited group of patients, citing concerns over side effects ...

A panel of the European medicines regulator has recommended approving an eco-friendly version of AstraZeneca's inhaler for ...

The European Medicines Agency (EMA) cleared the way for the use of another drug to treat Alzheimer's disease on Friday.

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...

Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping ...

European Medicines Agency recognizes potential of lead compound MP1032 in addressing a high unmet medical need in Duchenne Muscular Dystrophy (DMD)Designation is paving the way for safer long-term ...

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...

Eli Lilly said on Friday that the European Medicines Agency (EMA) has recommended approval of its drug Kisunla for certain ...

European regulators said that Eli Lilly’s Alzheimer’s treatment Kisunla should be approved for select patients.