Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
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Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
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Sarepta, Biogen drugs with accelerated approval under fire in FDA report
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 ...
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Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
(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 ...
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Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
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Dispatches From JPM, Biogen’s Sage Buyout Offer, Pfizer’s Obesity Play, More
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference.
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OS Therapies heading to FDA with positive osteosarcoma data
The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T ...
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Ionis plans phase 3 for Biogen-rejected Angelman drug
Biogen opted out of the development of INO582 ... Bamboo/Pfizer, and Stride Bio/Sarepta. Join the conversation, on Tuesday 28th January @ 10 am ET - 3 pm GMT - 4 pm CET, in our webinar sponsored ...
Multiple Sclerosis Treatment Market 2034: EMA, PDMA, FDA Approval, Clinical Trials, Epidemiology, Therapies and Companies by DelveInsight
Multiple Sclerosis companies are Immune Response BioPharma, Clene Nanomedicine, Genzyme, ImStem Biotechnology, Rho, Inc., ...