Sep 7, 2026
The FDA indicated it would reverse its earlier rejection of Regenxbio's gene therapy for a deadly childhood disease, stating that existing data would be sufficient to support an accelerated approval bid. The reversal represents a significant policy shift.
Multiple hospitals have received federal grand jury subpoenas regarding gender-affirming care for minors, indicating the Department of Justice has begun a criminal investigation into these medical practices.
Five years after a disastrous trial where some boys died while others had astonishing recoveries, Astellas is returning with a revised gene therapy treatment for X-linked myotubular myopathy (XLMTM), offering new hope to a devastated rare disease community.
Multiple new studies project that delaying hepatitis B vaccination after birth—as recommended in new U.S. policy that offers the vaccine only to at-risk infants—will lead to increased infections, decreased survival rates, and lifelong health complications among newborns.
A major multi-country study found that WHO-recommended first-line antibiotics for neonatal sepsis are likely to be effective in only one-quarter of infections in low- and middle-income countries, highlighting a critical gap in global infant health treatment protocols.