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

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

A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...

Scientists have discovered that inhaling xenon gas can activate brain immune cells to break down Alzheimer's-related plaques ...

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 ...

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...

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

The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with ...

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 ...

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.