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.
Atalanta Therapeutics has secured oversubscribed $97m in Series B financing to propel the Phase I trials of its RNA interference (RNAi) treatments targeting KCNT1-related epilepsy as well as Huntington’s disease.
Manas AI has officially launched for transforming new cancer medicines discovery.
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.
The US Food and Drug Administration (FDA) has granted approval for Amneal Pharmaceuticals’ three medications, memantine/donepezil extended-release capsules and everolimus tablets for oral suspension, with tentative approval for rifaximin oral tablets.
Kamada has secured a three-year contract with an international organisation to supply its KAMRAB and VARIZIG immune globulin products in Latin America from 2025 to 2027.
Health Canada has granted authorisation to Roche Canada's Vabysmo (faricimab injection) to be used in a 6.0 mg single-use pre-filled syringe (PFS) for treating diabetic macular oedema, wet or neovascular, age-related macular degeneration (AMD), and macular oedema secondary to retinal vein occlusion (RVO).
Guangzhou Fermion Technology and Simcere Pharmaceutical Group have announced a collaboration aiming to develop FZ002-037 for pain treatment.
Micron Biomedical has secured over $16m in a Series A3 financing round to expand the commercial manufacturing of its needle-free vaccines.
Cycle Pharmaceuticals has completed the acquisition of Banner Life Sciences, including BAFIERTAM (monomethyl fumarate) product, a US Food and Drug Administration (FDA)-approved treatment for relapsing forms of multiple sclerosis (MS) in the adult population.
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