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
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
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
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
Roche is preparing regulatory filings for its crovalimab antibody for rare disease paroxysmal nocturnal haemoglobinuria (PNH), after a phase 3 trial showed the drug was as
It’s 2024, and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another.