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.
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.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Novartis' Fabhalta (iptacopan) to treat the adult population with C3 glomerulopathy (C3G).
The US Food and Drug Administration (FDA) has granted fast track designation for Avobis Bio’s lead therapeutic candidate, AVB-114, for treating Crohn's perianal fistulas.
Health Canada has granted marketing authorisation to Kashiv BioSciences’ long-acting G-CSF biosimilar, Pegfilgrastim injection.
The US Food and Drug Administration (FDA) has granted approval for Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat adults with symptomatic tenosynovial giant cell tumour (TGCT).
The US Food and Drug Administration (FDA) has accepted to review Regeneron Pharmaceuticals’ resubmitted biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory (R/R) multiple myeloma (MM).
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) in adults.
Scholar Rock has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for muscle-targeted therapy, apitegromab, aimed at enhancing motor function in individuals with spinal muscular atrophy (SMA) who are already on SMN-targeted therapies.
The European Medicines Agency (EMA) has validated X4 Pharmaceuticals’ marketing authorisation application (MAA) submitted for mavorixafor, aimed at treating WHIM syndrome, a rare primary immunodeficiency.
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