Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug Administration (FDA) for the new drug application for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. Cyclophosphamide Injection is indicated in the US for malignant lymphomas, multiple myeloma, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, […]
US biopharma company Y-mAbs Therapeutics has submitted the first portions of its biologics license application (BLA) for naxitamab to the US Food and Drug Administration (FDA), seeking the drug’s approval for the treatment of relapsed/refractory high-risk neuroblastoma under the latter’s Rolling Review process. Naxitamab, an anti-GD2 monoclonal antibody, was granted the FDA breakthrough therapy designation […]
