The accelerated approval pathway is evolving in plain sight, with or without congressional help
FDA leaders have made clear that reforming the accelerated approval pathway is a priority, and with several recent actions, the agency has signaled that it’s willing to take action on those reforms even without immediate movement from Congress.
The latest sign of this evolution occurred today, as GSK announced it was pulling its fifth-line multiple myeloma drug Blenrep at the FDA’s request — just 15 days post-confirmatory trial fail announcement.
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