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

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Gilead ...

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

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

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

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 ...

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 ...

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

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 ...