The Sarepta and Biogen therapies mentioned are, respectively, Exondys 51 (eteplirsen) and Aduhelm (aducanumab). They are used for Duchenne muscular dystrophy and Alzheimer's disease. The FDA's ...

(Bloomberg) — Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs ...

For example, Sarepta has yet to complete its confirmatory ... The decision prompted three members of the panel to quit. Early last year, Biogen pulled the plug on the treatment.

Sarepta Therapeutics' Elevidys for DMD shows growing revenue potential, with management targeting >$3bn of total revenues in 2025, up 68% from 2024, led by gene therapy. Despite past valuation ...

Sarepta's EMBARK study confirms Elevidys offers sustained Duchenne treatment benefits, including motor function improvement and minimal muscle pathology progression. Solid Biosciences advances ...

(Bloomberg) -- Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal ...