FDA shakes up drug and biologics leadership after Makary's exit

The US Food and Drug Administration is changing the leaders of its drug and biologics centres, days after former commissioner Marty Makary stepped down. The reshuffle reaches the offices that sign off on new chemical drugs, biologic medicines, vaccines and advanced cell therapies. The agency framed the moves as a routine succession.

Industry executives told CNBC they were caught off guard by the timing, with several major new-drug applications already queued for decisions this summer. Investors in large drugmakers and biotech firms paid close attention because a single division chief can shape the speed of approvals across an entire category. Career staff are expected to absorb most of the workload during the transition.

The shakeup lands as the White House continues to push regulators to move faster on innovative therapies while questioning longstanding safety reviews. Lawmakers from both parties signaled they would request briefings from the new appointees before any major decisions are issued. The agency has not yet named an internal timeline for confirming the picks.