Biogen and Sage have received FDA approval for Zurzuvae, the first oral treatment for postpartum depression. PPD affects around 500,000 patients a year in the US. While the companies are happy with the approval, they were hoping to also receive approval to treat patients with major depressive disorder (MDD) with Zurzuvae as well. The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed.

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