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”

Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding

Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding

The recent first global approval of andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo] 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 “Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding”

Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP

Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP

The recent first global approval of fostamatinib 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 “Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP”

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”

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”

Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML

Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML

The recent first global approval of enasidenib 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 “Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML”

Niraparib (Zejula™): First Global Approval – Oral maintenance therapy for recurrent ovarian-related cancer

Niraparib (Zejula™): First Global Approval –  Oral maintenance therapy for recurrent ovarian-related cancer

The recent first global approval of niraparib 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 “Niraparib (Zejula™): First Global Approval – Oral maintenance therapy for recurrent ovarian-related cancer”

Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma

Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma

The recent first global approval of avelumab 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 “Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma”

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

The recent first global approval of telotristat ethyl 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 “Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome”