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”
Tag: US
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”