Hosted on MSN15d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
The report was prompted by the FDA's 2021 approval of the Alzheimer's disease drug aducanumab (Aduhelm) using the accelerated approval pathway. The aducanumab approval raised concerns in Congress ...
Hosted on MSN17d
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 ...
Boston College6d
Medicare and prescription drug costs
Aduhelm generated hopes in the public and medical community alike when it was developed several years ago under the name aducanumab by Biogen Inc., but disappointing results from initial trials of the ...
pharmaphorum3d
Aduhelm and an expensive failure to launch
From the beginning, the approval of its Aduhelm (aducanumab) treatment was met with controversy – over the interactions with the FDA, and the advisor committee’s vote against the treatment ...