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”

Durvalumab (Imfinzi™): First Global Approval – Empower the host – disarm the disease; immune-stimulation brings hope in bladder cancer

Durvalumab (Imfinzi™): First Global Approval – Empower the host – disarm the disease;  immune-stimulation brings hope in bladder cancer

The recent first global approval of durvalumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1] based on the development milestones tracked in AdisInsight.[2] Continue reading “Durvalumab (Imfinzi™): First Global Approval – Empower the host – disarm the disease; immune-stimulation brings hope in bladder cancer”