HealthNotableReported
5.2
Ex-US FDA official Li Zili to head Hong Kong medical products regulator
South China Morning PostLO·HK · US · CN·3 days ago
Ascelia Pharma shares fell sharply after the FDA reaffirmed its requirement for a new study of Orviglance, the same candidate that triggered a 75% collapse in July. The decision confirms the regulatory setback and prolongs uncertainty over the drug's approval timeline. This is a company-specific event with no broader market implications.