The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

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 ...

Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better fortunes with their next Alzheimer's disease therapy lecanemab, which is now fully filed with the FDA.

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

A government watchdog examining the FDA’s accelerated approval pathway has released a 32-page report (PDF) that concludes the agency’s controversial endorsement of Biogen’s failed Alzheimer ...

Equities research analysts at Wedbush dropped their FY2024 EPS estimates for Biogen in a research report issued on Thursday, ...

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 ...

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 Aduhelm was withdrawn from the market.

Stock analysts at Wedbush lowered their Q4 2024 earnings estimates for Biogen in a research report issued on Thursday, January 23rd. Wedbush analyst L. Chico now forecasts that the biotechnology ...

As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and ...