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 ...
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 ...
Despite Leqembi's initial slow sales, the firm's CEO cited areas for the drug's growth and ambitions for an antisense ...
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 ...
The FDC released a second highly critical report of PBMs, which may provide further impetus for legislative action to curb ...
Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.
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