The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Amgen’s humanised monoclonal antibody Uplizna (inebilizumab-cdon) to treat the adult population with immunoglobulin G4-related disease (IgG4-RD), an immune-mediated inflammatory condition that impacts several organs.
The US Food and Drug Administration (FDA) has granted clearance for an investigational new drug (IND) application of Epicrispr Biotechnologies’ EPI-321, intended for treating genetic neuromuscular condition, facioscapulohumeral muscular dystrophy (FSHD).
Biogen has received fast track designation from the US Food and Drug Administration (FDA) for its investigational antisense oligonucleotide (ASO) therapy, BIIB080, to treat Alzheimer's disease.
Pharvaris has secured orphan designation from the European Commission (EC) for deucrictibant, an investigational drug for treating bradykinin-mediated angioedema.
The Ministry of Health, Labour and Welfare (MHLW) in Japan has authorised Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) for treating chronic obstructive pulmonary disease (COPD) in adults.
BridgeBio Pharma has received the Japanese Ministry of Health, Labour and Welfare approval for Beyonttra, a brand name for acoramidis, for treating adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).
The US Food and Drug Administration (FDA) has granted approval to Exelixis' Cabometyx (cabozantinib) for treating specific types of advanced neuroendocrine tumours (NET) in both adult and paediatric patients aged 12 and older.
Palatin Technologies has secured orphan drug designation from the US Food and Drug Administration (FDA) for PL7737, an oral treatment targeting leptin receptor (LEPR) deficiency obesity.
The US Food and Drug Administration (FDA) has granted approval for Novartis’ Fabhalta (iptacopan), intended to minimise proteinuria in the adult population with C3 glomerulopathy (C3G).
Health Canada has granted approval for Arcutis’ topical formulation Zoryve (roflumilast cream 0.15%) for mild to moderate atopic dermatitis (AD) treatment in adults and paediatrics aged six years and above.
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