Despite safety, efficacy concerns, FDA AdCom narrowly recommends Mallinckrodt drug
A day after the FDA detailed significant concerns about just how effective or safe an experimental Mallinckrodt liver drug was, an advisory committee decided by a single vote to recommend it for approval.
“I voted yes to approve, but I also wrote in, ‘but barely,’” Paul Ridker, a cardiologist at Brigham and Women’s Hospital and one of the panelists, said at the meeting, according to FierceBiotech. The vote was 8-7.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
