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 ...

The positive results from the second part of the EMBARK trial contrast with findings from one-year post treatment, which did ...

(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 ...

The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...

No new safety signals were observed. As part of a collaboration agreement signed in 2019, Sarepta is working with Roche Holdings AG RHHBY. Sarepta is responsible for regulatory approval and ...

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

Sarepta’s (SRPT) net product revenue does not include collaboration, contract manufacturing or royalty revenue. Fourth quarter and full-year 2024 net product revenue for ELEVIDYS totaled $384.2M ...

In a report released today, Uy Ear from Mizuho Securities maintained a Hold rating on SAGE Therapeutics (SAGE – Research Report), with a price ...

(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 ...