Regulatory Daily Summary
Regulatory Daily Summary: What Happened on October 31, 2026
FDA advisers favor another Sydnexis trial for pediatric myopia drug
The panel questioned whether SYD-101’s Phase III results showed a clinically meaningful benefit, although the lower dose met prespecified endpoints.
Today in brief
The advisory panel backed further testing of Sydnexis’ low-dose atropine treatment, concluding the evidence had not established meaningful benefit for children with myopia.1
Also published
- At least 11 PDUFAs on FDA’s November docket BioCentury