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Daniel Cressy’s story is a powerful glimpse into the real-world era of gene therapy—and a reminder that access may become the next frontier.
Regenxbio says FDA no longer requires additional studies before reviewing Navsunli/RGX-121 for accelerated approval, a potentially important rare-disease regulatory signal.
A new FDA draft guidance and a series of recent reversals suggest the biggest bottleneck in gene therapy may no longer be the science alone. It may be the approval process itself.
Sanofi’s Cenrifki/tolebrutinib was approved in the EU for secondary progressive multiple sclerosis without recent relapses, where disability can worsen even without flare-ups.
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