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.

Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) is one of the Stocks With Huge Catalysts on the Horizon. On July 25, Ionis ...

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

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

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. Scientists say this ...

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

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.

Eli Lilly and Co. won the backing of European Union regulators for its Alzheimer’s disease drug Kisunla in a specific group ...