Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.
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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, ...
Alzheimer’s drugs eyed as next big obesity-like opportunity
Investors seeking the next obesity-like market opportunity will be closely watching developments related to treatments for ...
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 approval for drugs to fill unmet needs, federal watchdogs said in a report.
Biogen lays out three FDA decisions that could ramp up Alzheimer's drug launch
Since its approval in 2023, the Alzheimer's disease drug made by Biogen Inc. and Eisai has seen a lackluster launch. However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of ...
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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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Biogen’s ‘cold and calculated’ offer to buy Sage receives a mixed reaction on Wall Street
Analysts say the deal, which would give Biogen full control over the drug Zurzuvae, could be a smart financial move. Yet it's ...
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Sage sues Biogen after unsolicited takeover bid
Meanwhile, Sage reported failed phase 2 trials of dalzanemdor in Alzheimer's, Parkinson's, and Huntington's disease, and ...
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Biogen CEO Chris Viehbacher targets subcutaneous Leqembi release for Alzheimer’s treatment
Biogen CEO Chris Viehbacher targets subcutaneous Leqembi release for Alzheimers treatment Biogens Chris Viehbacher outlines ...