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A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.

David Chang will leave his post after an eight-year run at the cell therapy maker. Elsewhere, a next-generation blood disease drug stumbled and an acquisition yielded an FDA approval for AbbVie.

As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.