Non-metastatic Castration-resistant Prostate Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-07-09FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for ERLEADA (apalutamide) by Janssen Products, LP, prompting changes to the product labeling. The ac…
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FDA approval · 2023-12-19FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for ERLEADA (apalutamide) filed by Janssen Products, LP. The approval updates the drug's labelin…
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FDA approval · 2023-11-16FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc., updating the drug's labeling.
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FDA approval · 2023-02-17FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP. The approval expands the drug's label f…
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FDA approval · 2022-11-08FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for Erleada (apalutamide) submitted by Janssen Products, LP.
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FDA approval · 2022-08-05FDA Approved: NUBEQA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for NUBEQA (darolutamide) from Bayer HealthCare Pharmaceuticals Inc.
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FDA approval · 2022-04-26FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for ERLEADA (apalutamide) filed by Janssen Products, LP.
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FDA approval · 2021-07-14FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP.
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FDA approval · 2020-10-23FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) from Astellas Pharma US to modify/expand its label for prostate cancer ind…
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FDA approval · 2020-07-10FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP, resulting in an expanded or updated…
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FDA approval · 2019-07-30FDA Approved: NUBEQA — Original Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved NUBEQA (darolutamide) through an original application for the treatment of non-metastatic castration-resistant prostate can…
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FDA approval · 2018-02-14FDA Approved: ERLEADA — Original Application (Janssen Products, LP)
FDA approved ERLEADA (apalutamide) from Janssen Products, LP as the original NDA (NDA210951). It is approved for certain forms of prostate c…
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FDA approval · 2015-08-05FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc. The approval expands the labelin…