Healio1d
FDA accepts new drug application for SYD-101 to treat pediatric myopia progression
The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...
Ophthalmology Times1d
FDA accepts new drug application for low-dose atropine from Sydnexis
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
Morningstar2d
Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia
FDA assigns a PDUFA target action date of October 23, 2025 If approved, SYD-101 would be the first and only pharmaceutical treatment option proven to slow the progression of pediatric myopia ...
MPR1d
Low-Dose Atropine Eye Drops Under Review for Pediatric Myopia
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SYD-101 (atropine sulfate) to slow the progression of ...
Business Wire2d
Sydnexis Announces FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia
If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States. “The FDA acceptance of our NDA filing for SYD ...