Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

The Alzheimer’s Association advised against diagnosing the disease on biomarkers alone, but other experts said the genie ...

In June 2021, the Food and Drug Administration approved aducanumab, an amyloid beta-targeted drug, under the “accelerated approval” program for patients diagnosed with Alzheimer’s.

The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...

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 ...

In June 2021, the Food and Drug Administration approved aducanumab, an amyloid beta-targeted drug, under the “accelerated approval” program for patients diagnosed with Alzheimer’s. This pathway allows ...

It has also given accelerated approval for aducanumab (Aduhelm). While three drugs have been approved, the treatments didn't prove to be as effective as thought. Aduhelm was withdrawn from the market.

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 ...