Partner Therapeutics has received the US Food and Drug Administration (FDA) approval for Bizengri (zenocutuzumab-zbco) to treat adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring a neuregulin 1 (NRG1) gene fusion and who have progressed on or after prior systemic therapy.
Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for Sotyktu (deucravacitinib) to treat active psoriatic arthritis (PsA).
Sunshine Lake Pharma, Lannett and its wholly owned subsidiary Lanexa Biologics have received approval from the US Food and Drug Administration (FDA) for Langlara (insulin glargine-aldy), an interchangeable biosimilar of Lantus (insulin glargine).
Arrowhead Pharmaceuticals has received approval from the Australian Therapeutic Goods Administration (TGA) for Redemplo (plozasiran) to treat familial chylomicronemia syndrome (FCS).
Axsome Therapeutics has received the US Food and Drug Administration (FDA) approval for Auvelity (dextromethorphan HBr and bupropion HCl) to treat agitation associated with dementia due to Alzheimer’s.
AstraZeneca has received approval from the US Food and Drug Administration (FDA) for the subcutaneous self-administration of Saphnelo (anifrolumab-fnia) using the Saphnelo Pen autoinjector for systemic lupus erythematosus (SLE).
Novartis has netted a pair of regulatory wins, winning European approval for an oral therapy in chronic spontaneous urticaria (CSU) and, separately, receiving World Health Organization (WHO) prequalification for its antimalarial medication.
Travere Therapeutics has received the US Food and Drug Administration (FDA) full approval for Filspari (sparsentan) to reduce proteinuria in adult and paediatric patients aged eight years and above with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
Merck & Co (MSD) and Daiichi Sankyo have received priority review from the US Food and Drug Administration (FDA) for ifinatamab deruxtecan’s biologics licence application (BLA) to treat extensive-stage small cell lung cancer (ES-SCLC).
Merck (MSD) has received the European Commission (EC) approval for Keytruda (pembrolizumab) along with paclitaxel, with or without bevacizumab, as a treatment for programmed death-ligand 1 (PD-L1)-positive ovarian cancer.
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