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 ...

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

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 ...

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 ...

Sage (SAGE) is reportedly suing Biogen (BIIB) over enforcement of a standstill agreement in the wake of an unsolicited ...

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

The approval of Calquence marks the first and only BTK inhibitor approved for the first-line treatment of MCL in the US.