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 ...

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 ...

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 ...

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 ...

An advisory committee to the Ministry of Health, Labour and Welfare (MHLW) has declined to approve Aduhelm (aducanumab), saying the data from its two main clinical trials is hard to interpret ...