Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
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, ...
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 ...
J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference.
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 ...
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.
Sarepta Therapeutics exceeded 2024 net product revenue guidance and reaffirmed its 2025 outlook, partly due to strong growth for Duchenne muscular dystrophy drug Elevidys. The company reported ...
Sarepta (SRPT) Therapeutics announced that enrollment and dosing is complete in EMERGENE or Study SRP-9003-301 , a Phase 3 clinical trial of SRP-9003 or bidridistrogene xeboparvovec . SRP-9003 is ...
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