FDA granted Priority Review to Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The agency also accepted the drug’s supplemental new drug application designed to support the conversion of accelerated approval to full approval and expand the current Kyprolis indication. FDA set a target action date of July 26.
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.