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”

Tagraxofusp (Elzonris™): First Global Approval – Breakthrough therapy for BPDCN and novel CD123-targeted therapy

Tagraxofusp (Elzonris™): First Global Approval – Breakthrough therapy for BPDCN and novel CD123-targeted therapy

The recent first global approval of tagraxofusp (Elzonris™) 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].

In December 2018, tagraxofusp, developed by Stemline Therapeutics, was approved by the United States Food and Drug Administration (FDA) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children 2 years and older.[1][3] Continue reading “Tagraxofusp (Elzonris™): First Global Approval – Breakthrough therapy for BPDCN and novel CD123-targeted therapy”

Delafloxacin (Baxdela™): First Global Approval – Flexible dosing, broad spectrum coverage, effective against resistant pathogens – appealing characteristics for the treatment of ABSSSI

Delafloxacin (Baxdela™): First Global Approval – Flexible dosing, broad spectrum coverage, effective against resistant pathogens – appealing characteristics for the treatment of ABSSSI

The recent first global approval of delafloxacin 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 “Delafloxacin (Baxdela™): First Global Approval – Flexible dosing, broad spectrum coverage, effective against resistant pathogens – appealing characteristics for the treatment of ABSSSI”