3 ms·
The FDA evaluated evidence that the same drug would help treat major depressive disorder and found it lacking; https://www.fiercepharma.com/pharma/sage-biogens
by mikeyouse 3y ago
The FDA evaluated evidence that the same drug would help treat major depressive disorder and found it lacking;
https://www.fiercepharma.com/pharma/sage-biogens-postpartum-depression-approval-overshadowed-larger-depression-rejection https://www.fiercepharma.com/pharma/sage-biogens-postpartum-...
> Alongside Friday’s approval, the partners also received a rejection for Zurzuvae in adults with major depressive disorder (MDD). The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed. Sage and Biogen said they are reviewing possible next steps.
- esel2k 3y agoWhich immediately leads to layoffs: https://www.fiercebiotech.com/biotech/sage-braces-layoffs-pipeline-culls-shares-tank-wake-zuranolones-mdd-rejection https://www.fiercebiotech.com/biotech/sage-braces-layoffs-pi...