The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...
A wide-reaching Trump Administration order disrupted systems nationwide and left millions unsure if they will lose access to jobs, housing and health care. Institutions in Long Beach are scrambling to ...
As I ran from interview to interview across San Francisco, I was consistently warmed by the stories I was told by biotech and ...
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
Roll Call reports that the newly finalized rule will allow for health care providers who have not seen a patient in person to prescribe six months’ worth of buprenorphine via telehealth. Also in ...
Scientists have discovered that inhaling xenon gas can activate brain immune cells to break down Alzheimer's-related plaques ...
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 ...
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.
The FDC released a second highly critical report of PBMs, which may provide further impetus for legislative action to curb ...
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