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 ...

A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...

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 said in a report.

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

J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and ...

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Biogen opted out of the development of INO582 ... Bamboo/Pfizer, and Stride Bio/Sarepta. Over 6.3 million patients make up the NHS backlog for consultant-led elective care, which reached 7,573,212 ...