Soliris

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FDA clears Amgen’s Bkemv as first biosimilar of Soliris

The US FDA has approved the first biosimilar version of AstraZeneca/Alexion’s Soliris therapy for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemi

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Novartis’ Fabhalta is first FDA-cleared oral therapy for PNH

Novartis’ targeted factor B inhibitor iptacopan has become the first oral monotherapy to be approved by the FDA for rare blood disorder paroxysmal nocturnal haemoglobinuri

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FDA starts review of Roche's PNH drug crovalimab

Roche could be just months away from FDA approval of its anti-complement C5 antibody crovalimab, after the US regulator started a review of its marketing application as a

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Regeneron gets FDA blessing for CHAPLE drug Veopoz

Patients with the ultra-rare disease CHAPLE now have their first FDA-approved therapy, after the regulator approved Regeneron's pozelimab for people aged one and over with

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Soliris becomes first drug for paediatric gMG in Europe

AstraZeneca's Soliris has become the first approved treatment in the EU for children and adolescents with generalised myasthenia gravis, a disorder that causes weakness in

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