Otsuka Pharmaceutical Co.’s medicine for post-traumatic stress disorder with partner H. Lundbeck A/S failed to win the backing of US regulatory advisers, a major setback in the drugmakers’ bid to ...

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after ...

Massachusetts-based Sarepta Therapeutics, facing scrutiny from regulators, is reducing its global workforce by 36% in an ...

Ice cream makers representing about 90% of the U.S. supply of the frozen treat have pledged to remove artificial dyes from ...

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...

“Now, by expanding the palette of available colors derived from natural sources, food manufacturers have a variety of options ...

Sarepta Therapeutics shares plunge over 37% as FDA weighs halting shipments of its key gene therapy, Elevidys, after patient ...

The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a ...

Sarepta Therapeutics saw its shares plunge more than 35% Friday after a third patient death tied to its gene therapy programs ...