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.
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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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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OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
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After 2 Deaths, Philips Recalls Software That Mishandled Some EKG Readings
Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...
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., ...
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The hypometabolic state: a good predictor of a better prognosis in amyotrophic lateral sclerosis
PF, NG and EC have nothing to disclose. VS participates in Advisory Boards or Teaching activities for Biogen, Roche, Avexis, PTC, Santhera, Sarepta, Dyne. LL received honoraria for consulting services ...
Sarepta Therapeutics: Strong Financial Performance and Promising Growth Prospects Justify Buy Rating
Leerink Partners analyst Joseph Schwartz has reiterated their bullish stance on SRPT stock, giving a Buy rating yesterday.Stay Ahead of the ...
Sarepta Therapeutics: Strong Financial Performance and Promising Outlook Justify Buy Rating
Mizuho Securities analyst Uy Ear has assigned their bullish stance on SRPT stock, giving a Buy rating yesterday.Stay Ahead of the ...
Breadth of Q4 S&P earnings growth is key amid 'Mag 7' dominance: Goldman Sachs
Analysts at Goldman Sachs predict the Magnificent 7 stocks will continue to dominate, but the growth differential may narrow ...
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Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...