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Regulatory actions for July 27, 2026

AI Briefing

  • • Alfasigma's ibrutinib tablet received US FDA approval for chronic lymphocytic leukemia.
  • • Zevra's tafamidis tablet was approved for hereditary transthyretin-mediated amyloidosis in EU.
  • • Gilead's filgotinib tablet received EU approval for rheumatoid arthritis treatment.

Source Summary

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Alfasigma, Astrazeneca, Daiichi, Gilead, Mannkind, Menarini, Minoryx, Neuraxpharm, Newamsterdam, Roche, Zevra.

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