Sage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression. The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June. Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth […]
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FDA extends decision date for Sage’s postpartum depression injection
Sage Therapeutics (NSDQ:SAGE) said today that the FDA extended its decision date for Sage’s Zulresso brexanolone injection to March 19, 2019. The U.S. regulatory agency was previously slated to decide whether or not to approve the drug as a treatment for postpartum depression by Dec. 19. The Cambridge, Mass.-based company noted that the FDA elected to […]
Sage Therapeutics’ chief scientist on discovering drugs and taking risks
When Al Robichaud got his start as a medicinal chemist in 1991, he knew that discovering and developing drugs meant shouldering some level of risk. But around 2011, it became clear that the process for developing brain drugs was too costly and risky for major pharmaceutical companies to justify pursuing, as companies including Novartis (NYSE:NVS), GlaxoSmithKline (NYSE:GSK), […]
Sage Therapeutics wins priority review for intravenous postpartum depression drug
Sage Therapeutics (NSDQ:SAGE) said today that the FDA accepted its new drug application for an intravenous formulation of brexanolone as a treatment for postpartum depression. The application was accepted under priority review status, according to the Cambridge, Mass.-based company. If approved, the drug would be the first therapy specifically indicated to treat postpartum depression – […]
