Breaking News, Trials & Filings

FDA Grants Priority Review to Janssen Biotech

The NDA is for apalutamide, a treatment for prostate cancer

The U.S. Food and Drug Administration has granted Priority Review designation for Janssen Biotech’s New Drug Application (NDA) for apalutamide, an investigational, next-generation oral androgen receptor (AR) inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC. “The prognosis for men with prostate cancer is significantly worse once the cancer has sprea...

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