Approvals

Japan’s MHLW authorises Regeneron and Sanofi’s Dupixent for COPD

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’s Beyonttra gains approval in Japan for ATTR-CM treatment

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).

US FDA approves Exelixis’ Cabometyx for advanced neuroendocrine tumours

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.

US FDA grants orphan drug status to Palatin’s obesity treatment PL7737

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.

FDA approves Novartis’ Fabhalta for C3 glomerulopathy treatment

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 approves Arcutis’ roflumilast cream 0.15% for atopic dermatitis

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.

FDA grants orphan drug status for Korro Bio’s AATD therapy

The US Food and Drug Administration (FDA) has granted orphan drug designation for Korro Bio’s KRRO-110 to treat alpha-1 antitrypsin deficiency (AATD).

UK MHRA approves Vertex’s Alyftrek for cystic fibrosis

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Vertex Pharmaceuticals’ triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), for treating cystic fibrosis (CF) in individuals aged six years and above.

FDA approves Celltrion’s biosimilars for various indications

The US Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), the biosimilars referencing Amgen’s Prolia and Xgeva, respectively.