FDA approves Zulresso of Sage
Sage Therapeutics, a clinical-stage biopharmaceutical company committed to the treatment of central nervous system (CNS) disorders, receives U.S. approval for its postpartum depression (PPD) drug Zulresso from the Food and Drug Administration when received 17-1 in favour of the therapy's risk-benefit profile. The supporting vote was largely expected but came with a proviso: committee experts agreed that the injectable drug would be best used through a Risk Evaluation and Mitigation Strategy (REMS) program. Zulresso would become the first drug specifically approved by the FDA for the treatment of PPD.
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