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 ...
FiercePharma23h
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 ...
BioSpace2d
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, ...
Sarepta Therapeutics: Guidance Suggests A Year Of Upside Likely
Sarepta Therapeutics' Elevidys for DMD shows revenue potential, with market cap justified at $11.4bn and potential for >50% ...
Temporary Revenue Surge and Market Penetration Concerns Lead to Sell Rating for Sarepta Therapeutics
Analyst Mitchell Kapoor from H.C. Wainwright reiterated a Sell rating on Sarepta Therapeutics (SRPT – Research Report) and keeping the price ...
BioPharma Dive2d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
BioSpace1d
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.
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 ...
Seeking Alpha2d
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 ...
Mint2d
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 ...