Castration-resistant Prostate Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-07-31FDA Approved: PLUVICTO — Supplemental Application (Novartis Pharmaceuticals Corporation)
Supplemental application for PLUVICTO (lutetium Lu-177 vipivotide tetraxetan) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2026-04-07FDA Approved: PLUVICTO — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for PLUVICTO (lutetium Lu-177 vipivotide tetraxetan) from Novartis, signaling an updated regulatory …
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EMA approval · 2026-03-17EMA Authorised: Akeega (abiraterone acetate;niraparib (tosilate monohydrate)) — Janssen-Cilag International N.V.
EMA authorised Akeega, a fixed-dose combination of abiraterone acetate and niraparib (tosilate monohydrate) for castration-resistant prostat…
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EMA approval · 2026-02-18EMA Authorised: Pluvicto (lutetium (177Lu) vipivotide tetraxetan) — Novartis Europharm Limited
The EMA authorised Pluvicto (lutetium-177 vipivotide tetraxetan) for metastatic castration-resistant prostate cancer. It is a PSMA-targeted …
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EMA approval · 2026-01-07EMA Authorised: Cabazitaxel Accord (cabazitaxel) — Accord Healthcare S.L.U.
The European Medicines Agency authorised Cabazitaxel Accord for castration-resistant prostate cancer. The marketing authorization holder is …
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EMA approval · 2025-08-29EMA Authorised: Nubeqa (darolutamide) — Bayer AG
The EMA authorised Nubeqa (darolutamide) for use in castration-resistant prostate cancer, expanding the drug's EU indication for Bayer AG as…
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CLINICAL_TRIALS approval · 2025-06-13Clinical Trial Update: Pre-approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination)
A pre-approval access, single-patient request for the niraparib and abiraterone acetate combination in metastatic castration-resistant prost…
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FDA approval · 2025-05-19FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for abiraterone acetate from Mylan Pharmaceuticals, authorizing a generic version to be marketed. Ab…
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FDA approval · 2025-03-28FDA Approved: PLUVICTO — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for PLUVICTO (lutetium Lu-177 vipivotide tetraxetan) from Novartis Pharmaceuticals Corporation. The …
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FDA approval · 2024-10-28FDA Approved: ABIRATERONE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Abiraterone acetate under an ANDA.
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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 · 2023-11-16FDA 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 · 2023-08-11FDA Approved: AKEEGA — Original Application (Janssen Biotech, Inc.)
FDA approved AKEEGA, a fixed-dose combination of niraparib tosylate monohydrate and abiraterone acetate. This represents an original applica…
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FDA approval · 2023-07-07FDA Approved: JEVTANA — Supplemental Application (Sanofi-Aventis U.S. LLC)
The FDA approved a supplemental application for JEVTANA (cabazitaxel) submitted by Sanofi-Aventis U.S. LLC.
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FDA approval · 2023-03-23FDA Approved: ABIRATERONE ACETATE — Original Application (Florida Pharmaceutical Products, LLC)
FDA approved an abbreviated new drug application for a generic version of abiraterone acetate from Florida Pharmaceutical Products, LLC, for…
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FDA approval · 2022-09-02FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental application for abiraterone acetate (ABIRATERONE) from Amneal Pharmaceuticals NY LLC, authorizing changes to…
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FDA approval · 2022-09-02FDA Approved: ABIRATERONE — Supplemental Application (BluePoint Laboratories)
FDA approved a supplemental application for Abiraterone acetate (ANDA 210686) from BluePoint Laboratories, authorizing the continued manufac…
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FDA approval · 2022-08-31FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for abiraterone acetate from Mylan Pharmaceuticals Inc., enabling a generic version of the cance…
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FDA approval · 2022-05-19FDA Approved: ABIRATERONE ACETATE — Supplemental Application (NORTHSTAR RX LLC)
FDA approved a supplemental application for Abiraterone acetate from Northstar RX LLC, resulting in approval of a generic product under ANDA…
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FDA approval · 2022-03-28FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Florida Pharmaceutical Products, LLC.)
The FDA approved a supplemental application for Abiraterone Acetate (generic) submitted by Florida Pharmaceutical Products, LLC.
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FDA approval · 2022-03-24FDA Approved: YONSA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for YONSA (abiraterone acetate), a prostate cancer therapy. The approval authoriz…
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FDA approval · 2022-03-23FDA Approved: PLUVICTO — Original Application (Novartis Pharmaceuticals Corporation)
The FDA approved Pluvicto (lutetium Lu-177 vipivotide tetraxetan) from Novartis as an original approval for metastatic castration-resistant …
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FDA approval · 2022-01-28FDA Approved: YONSA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for YONSA (abiraterone acetate) submitted by Sun Pharmaceutical Industries, Inc. under NDA 21030…
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FDA approval · 2022-01-05FDA Approved: ABIRATERONE ACETATE — Original Application (Novugen Pharma (USA) LLC)
FDA approved a generic version of abiraterone acetate from Novugen Pharma (USA) LLC via an Original Application (ANDA) for metastatic castra…
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FDA approval · 2021-12-20FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Dr. Reddys Laboratories Inc)
The FDA approved a supplemental application for Abiraterone Acetate from Dr. Reddy's Laboratories Inc, enabling a generic version of the dru…