Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

Shots:The EC has approved SYD-101 to slow pediatric myopia progression; NDA is under the US FDA’s review (PDUFA: Oct 23, 2025)Approval was based on P-III (STAR) trial evaluating SYD-101 to reduce pediatric myopia progression & risk of associated co-morbidities in pts (3-14yrs. at trial initiation), which met its 3yr. 1EP, with third-year data…

ByRidhi RastogiJune 6, 2025

INSIGHTS+

Insights+: The US FDA New Drug Approvals in September 2022

The US FDA approved 12 NDAs and 4 BLA in September 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 63 novel products in 2022In September 2022, the major highlights drugs were Spevigo’s approval for generalized pustular psoriasis flares, Imfinzi for advanced biliary tract cancer, Retevmo…

BySenior EditorOctober 20, 2022

Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

Insights+: The US FDA New Drug Approvals in September 2022

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