Retevmo FDA approval : Eli Lilly and Company (Lilly) has secured approval from the US Food and Drug Administration (FDA) for Retevmo (selpercatinib, 40mg and 80mg capsules) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Retevmo has also been approved by the FDA for the treatment […]
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 […]
