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”

Roxadustat (Ai Rui Zhuo® in China): First Global Approval – First-in-class small molecule for anaemia in patients with DD-CKD

Roxadustat (Ai Rui Zhuo® in China): First Global Approval – First-in-class small molecule for anaemia in patients with DD-CKD

In December 2018, roxadustat, developed by FibroGen, in collaboration with Astellas and AstraZeneca, received its first global approval in China for the treatment of anaemia in patients with dialysis-dependent chronic kidney disease (DD-CKD).[1] Roxadustat is expected to launch in China in the second half of 2019.[2]

Continue reading “Roxadustat (Ai Rui Zhuo® in China): First Global Approval – First-in-class small molecule for anaemia in patients with DD-CKD”

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”

Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection

Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection

The recent first global approval of Ibalizumab 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].

Ibalizumab (Trogarzo™) developed by TaiMed Biologics received its first global approval in March 2018 in the US for the treatment of heavily treatment-experienced patients with multidrug resistant HIV-1 infection in combination with other antiretroviral medicines. Continue reading “Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection”

Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia

Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia

The recent first global approval of burosumab 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 “Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia”

Durvalumab (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA

Durvalumab (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA

In February 2018, durvalumab (IMFINZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy.[1] Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA”

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

The recent first global approval of acalabrutinib 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 October 2017, acalabrutinib (Calquence®), developed by Acerta Pharma, received its first global approval in the US for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Continue reading “Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma”

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

The recent first global approval of abemaciclib 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 “Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer”

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

The recent first global approval of glecaprevir/pibrentasvir 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 “Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!”

Cerliponase Alfa (Brineura™): First Global Approval – first flicker of hope for families living with CLN2

Cerliponase Alfa (Brineura™): First Global Approval – first flicker of hope for families living with CLN2

The recent first global approval of cerliponase alfa 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 “Cerliponase Alfa (Brineura™): First Global Approval – first flicker of hope for families living with CLN2”