Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy.

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

The panel voted 10-1 to say the available data does not establish the efficacy of the drug, brexpiprazole, in combination ...

The Trump administration’s proposed cuts to medical research and health agencies will curtail the development of promising ...

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a ...

Pasteurization is the process of heating a food product for a certain amount of time to destroy bacteria and viruses present, according to the Centers for Disease Control and Prevention (CDC). Dairy ...

Delta-8 is a substance found in the cannabis sativa plant, of which marijuana and hemp are two varieties, the agency said.