Sarepta Therapeutics, Inc.

The US Food and Drug Administration’s July advisory committee schedule includes a curious mix of vaccine safety reviews and the potentially triumphant return of a pulled multiple myeloma drug, in addi

Sarepta Therapeutics is hoping to streamline development across its pipeline of gene therapies for limb-girdle muscular dystrophies thanks to a US Food and Drug Administration platform technology des

The latest readout of data from Regenxbio’s Phase I/II AFFINITY DUCHENNE study of its gene therapy RGX-202 in Duchenne muscular dystrophy (DMD) offers more support for the firm’s plan to seek US Food

Vinay Prasad, the US Food and Drug Administration’s new director of the Center for Biologics Evaluation and Research, said his role in product reviews will be no different than previous center directo