Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
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 ...
With the prospects for its Alzheimer’s drug aducanumab still up in the air, Biogen has moved to shore up its late-stage pipeline with a $3 billion licensing deal with Sage that adds drugs for ...
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 ...
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 ...
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 ...
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