The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
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 ...
A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's ...
The FDA says vaping companies are improperly gaming the court system, filing claims in an appeals court they think will be sympathetic to them.
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...
The FDA has said it cannot approve tabelecleucel to treat patients 2 years of age and older who have EBV-positive PTLD and have received at least 1 prior therapy.
It's one of many steps for the company as it builds the infrastructure for what "will change medicine everywhere in the world ...
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