source
- US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deathsThree recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
- Takeda wins FDA nod for orexin drug oveporexton, first treatment for narcolepsy type 1 and potential broader usesTakeda received FDA approval for oveporexton (brand Orzeyful), an orexin receptor agonist, marking the first approved therapy that targets the orexin system for narcolepsy type 1. The drug mimics…