FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the ...
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 ...
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 accelerated approval process, and is using treatments from Sarepta Therapeutics ...
BioPharma Dive14d
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 procedures.
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a novel treatment to treat autism spectrum ...
BioSpace14d
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, ...
Becker's Hospital Review13d
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 ...