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FDA proposes framework for individualized...

The US Food and Drug Administration (FDA)...

FDA proposes framework for individualized gene therapies as CMS expands access

The US Food and Drug Administration (FDA) has proposed a regulatory framework for individualized human genome editing therapies, while the Centers for Medicare & Medicaid Services (CMS) plans to expand its Cell and Gene Therapy (CGT) Access Model beyond sickle cell disease. Together, these separate initiatives aim to support the development of therapies for rare genetic diseases and improve patient access to cell and gene therapies through Medicaid. Announced by the US Department of Health and Human Services (HHS) on 27 October 2026, the initiatives address two challenges in rare...
TOP-Pharma Editorial Team -
Biotech

FDA proposes framework...

The US Food and Drug Administration (FDA) has proposed a regulatory framework for individualized human genome editing therapies, while the Centers for Medicare &...
TOP-Pharma Editorial Team -
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