Sotagliflozin Gets FDA’s Blessing for Heart Failure
After a rocky development and regulatory road, the FDA has approved sotagliflozin (Inpefa) for treating heart failure in patients with or without diabetes, manufacturer Lexicon Pharmaceuticals announced on Friday. The dual SGLT1 and SGLT2 inhibitor is indicated for reducing the risk of cardiovascular death and urgent visits or hospitalization for heart failure in adults with […]
Accelerated Approval Not the Finish Line, Says FDA Commissioner
Drugmakers will no longer be able to slow-walk their accelerated approvals to full regulatory approval, said FDA Commissioner Robert Califf, MD, during the J.P. Morgan Healthcare Conference on Tuesday, while also fielding questions on gene therapies and the modernization of clinical trials, among other topics. Accelerated Approval When asked about the kind of data needed […]