The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
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 ...
The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...
Sydnexis, Inc. ( a pre-commercial stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration ...
Sydnexis recently completed its three-year primary endpoint in the pivotal Phase 3 clinical trial evaluating its proprietary low-dose atropine formulation to slow progression of pediatric myopia ...