FDA accepts resubmission of New Drug Application for unique formulation of sodium thiosulfate, Pedmark for prevention of cisplatin-induced ototoxicity in children with localised, non-metastatic solid tumours

The company notes that if approved, Pedmark stands to be the first therapy for prevention of cisplatin-induced hearing loss in children. The Marketing Authorization Application for sodium thiosulfate (Pedmarqsi) is currently under evaluation by the European Medicines Agency.

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Biospace Inc.