FDA approved Xalkori (crizotinib) to treat people with metastatic non-small cell lung cancer whose tumors have an ROS-1 gene alteration. Xalkori, sponsored by Pfizer, is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC. FDA previously granted the Xalkori expanded use application breakthrough therapy designation and priority review status.
The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.
A modest proposal from a former FDA commissioner: Add antidepressants to the nation’s water supply
Warning: This is not a public health recommendation. Do not implement.