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sagetherapeutics

Sage wins historic FDA nod for postpartum depression therapy

March 20, 2019 By Sarah Faulkner

Sage Therapeutics

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Wall Street Beat Tagged With: sagetherapeutics

FDA extends decision date for Sage’s postpartum depression injection

November 20, 2018 By Sarah Faulkner

Sage Therapeutics

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Wall Street Beat Tagged With: sagetherapeutics

Sage Therapeutics’ chief scientist on discovering drugs and taking risks

June 29, 2018 By Sarah Faulkner

Sage Therapeutics

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), […]

Filed Under: Discovery, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Wall Street Beat Tagged With: GlaxoSmithKline plc, Novartis, Pfizer Inc., sagetherapeutics, Sanofi-Aventis

Sage Therapeutics wins priority review for intravenous postpartum depression drug

May 30, 2018 By Sarah Faulkner

Sage Therapeutics

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 – […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: sagetherapeutics

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