Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...

As gene therapy maker Sarepta Therapeutics tangles with FDA over its Duchenne treatment, patients and their families are ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

South Korean medical students who walked out of school last year in protest at a government plan to increase medical school admissions said on Saturday that they would return to campus, calling on ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | Although many of the complete response letters uploaded by the FDA this ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse into the high-stakes discussions that decide whether a medicine will ever make ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli Lilly’s Alzheimer’s antibody Kisunla, Sarepta’s DMD gene therapy Vyondys 53 and ...

The FDA has turned down Capricor Therapeutics’ investigational cell therapy deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy, pointing to a lack of supporting ...

FDA turns back Capricor’s Duchenne cell therapy After scheduling, then canceling an advisory committee meeting, the agency rejected deramiocel for Duchenne-related cardiomyopathy, arguing Capricor ...