An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...

Investors seeking the next obesity-like market opportunity will be closely watching developments related to treatments for ...

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed approval for drugs to fill unmet needs, federal watchdogs said in a report.

Since its approval in 2023, the Alzheimer's disease drug made by Biogen Inc. and Eisai has seen a lackluster launch. However, Biogen CEO Chris Viehbacher said on Tuesday that there are a “number of ...

Sage Therapeutics' financials indicate a need for additional funding in 2025, risking dilution and further financial ...

The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...

Meanwhile, Sage reported failed phase 2 trials of dalzanemdor in Alzheimer's, Parkinson's, and Huntington's disease, and ...

Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...

The FDC released a second highly critical report of PBMs, which may provide further impetus for legislative action to curb ...

Biogen and Eisai have announced that the US Food and Drug Administration (FDA) has accepted a Biologics License Application ...