Drugmaker Sarepta Therapeutics said it won’t comply with a request from the FDA to halt all shipments of its gene therapy ...

The FDA has issued a Class II recall for over 110,000 ice cream boxes potentially contaminated with Listeria monocytogenes.

The FDA has issued a high-risk recall alert for certain fruits and vegetables due to contamination concerns. Consumers are urged to exercise caution and stay informed about the potential health risks ...

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 ...

In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...

The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but ...

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

The move follows the death of two teenagers who were administered the treatment, as well as the death of a 51-year-old ...

The FDA is set to request Sarepta Therapeutics to halt shipments of its gene therapy, Elevidys, after a third patient's death ...

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...

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

The FDA published their complete response letters to drug and biological product applications as part of an effort for more transparency.