Reata’s ‘regulatory concerns’ turn into three-month delay on FDA decision for Friedreich’s ataxia drug

In its Q2 report Monday, Reata Pharmaceuticals said that the FDA continues to have concerns about its Friedreich’s ataxia drug. On Tuesday, those concerns manifested in a three-month delay on an FDA approval decision. Reata’s new FDA decision deadline for its Friedreich’s ataxia drug, omaveloxolone, is the end of February 2023, it announced this morning. … Continue reading Reata’s ‘regulatory concerns’ turn into three-month delay on FDA decision for Friedreich’s ataxia drug