From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to ...

SRPT's Q2 report, set to arrive Aug. 6, is likely to have Elevidys updates, restructuring plans and sales outlook in sharp investor focus.

Hansa Biosciences’ Idefirix (imlifidase) has reduced patients’ antibodies to a level that allows dosing in patients with Duchenne muscular dystrophy (DMD) with Sarepta and Roche’s Elevidys ...

US Food and Drug Administration Commissioner Marty Makary said he’s trying to persuade Vinay Prasad, the agency’s former head of gene therapy and vaccines, to return to the FDA after his abrupt ...

Swedish biotech Hansa Biopharma on Friday released encouraging top-line results from three patients with Duchenne muscular ...

Hearing minnow Audeara has entered an alliance with Ear Science Institute Australia to develop an affordable bone conduction hearing device.

The global cancer gene therapy market size was US$ 1.5 billion in 2021. The global cancer gene therapy market is expected to grow to US$ 3.1 billion by 2030 by registering a compound annual growth ...

Investing.com -- US Food and Drug Administration Commissioner Marty Makary is attempting to convince Vinay Prasad, who recently left his position as head of gene therapy and vaccines, to return to the ...

Evidence-based medicine "Boy Wonder" Dr. Vinay Prasad was fired as CBER Director after less than three months on the job.

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect ...