FDA’s new leadership aims to restore reliability, but each application remains judged on its data

The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary.

Recent actions, such as the approval of Replimune’s advanced melanoma therapy and the agency’s willingness to work with Capricor to expand the data package for its Duchenne muscular dystrophy cell-therapy, are being cited as evidence of progress.

However, experts warn that these moves should not be read as a sign of regulatory leniency. Companies that faced difficult paths under the previous administration, including REGENXBIO and uniQure, are advised to continue focusing on robust data.

Investors had hoped the back-to-back advisory committee meetings for Capricor and Replimune would signal a more permissive stance, but analysts say the FDA’s decisions remain highly data-driven.