Brexanolone (Zulresso™): First Global Approval – First approved therapy for postpartum depression

Brexanolone (Zulresso™): First Global Approval – First approved therapy for postpartum depression

In March 2019, the small molecule brexanolone was approved by the United States Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adult women.[1] Brexanolone, developed by Sage Therapeutics under a license from the University of California, was granted priority review status and breakthrough therapy designation by the FDA.[2][3] Continue reading “Brexanolone (Zulresso™): First Global Approval – First approved therapy for postpartum depression”

Abaloparatide (Tymlos™): First Global Approval – bone formation fends off fragility fractures in postmenopausal women with high-risk osteoporosis

Abaloparatide (Tymlos™): First Global Approval – bone formation fends off fragility fractures in postmenopausal women with high-risk osteoporosis

The recent first global approval of abaloparatide has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight. Continue reading “Abaloparatide (Tymlos™): First Global Approval – bone formation fends off fragility fractures in postmenopausal women with high-risk osteoporosis”