A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
SLP highlighted its impact on the pharma industry through support of the development of a majority of the drugs approved by ...
(Bloomberg) -- Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators ... around transparency. While FDA records showed 13 meetings between ...
The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of ...
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 ...
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
The Biden administration announced Friday that Ozempic, Wegovy and 13 additional drugs will now be covered under Medicare ...
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