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Food and Drug Administration (FDA)
Biotech
Regenxbio gene therapy refiling plan derailed by FDA hold
The FDA put a hold on RGX-121 over spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy.
Nick Paul Taylor
Aug 24, 2026 7:51am
Trump taps White House aide as next FDA commissioner
Aug 19, 2026 10:17am
Capricor soars on plan to amend DMD filing after adcomm setback
Aug 14, 2026 10:20am
NIH joins Trump’s $5B AI mission with biomedical research push
Jul 22, 2026 2:43pm
Biotech leaders back FDA against ‘malicious’ abortion lawsuit
Jul 22, 2026 9:00am
FDA plans to release more CRLs as controversial policy resumes
Jul 14, 2026 2:50pm
