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.

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

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

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

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

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

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

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

The European Medicines Agency has granted orphan drug designation to narsoplimab for treatment in hematopoietic stem-cell transplant. About Hematopoietic stem cell transplant-associated thrombotic ...

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...