Prostate Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-03-11FDA Approved: BICALUTAMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for bicalutamide from Sun Pharmaceutical Industries, updating the existing generic approval.
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EMA approval · 2025-02-13EMA Authorised: Docetaxel Accord (docetaxel) — Accord Healthcare S.L.U.
The EMA authorised Docetaxel Accord (docetaxel) from Accord Healthcare for multiple cancer indications, including head and neck cancer, non-…
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FDA approval · 2025-02-11FDA Approved: CAMCEVI — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental application for CAMCEVI (leuprolide) from Accord BioPharma, Inc., expanding regulatory approval for this long-ac…
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FDA approval · 2025-01-22FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) filed by Astellas Pharma US, expanding its labeling for use in prostate ca…
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FDA approval · 2025-01-10FDA Approved: POSLUMA — Supplemental Application (Blue Earth Diagnostics)
The FDA approved a supplemental application for POSLUMA (flotufolastat F-18) from Blue Earth Diagnostics, expanding its labeling for PET ima…
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FDA approval · 2025-01-03FDA Approved: BICALUTAMIDE — Supplemental Application (Viona Pharmaceuticals Inc.)
FDA approved a supplemental application for Bicalutamide from Viona Pharmaceuticals Inc., authorizing changes to the approved generic drug.
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CLINICAL_TRIALS approval · 2024-12-19Clinical Trial Update: 18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
The update reports that the PSMA-targeted imaging agent 18F-DCFPyL used with PET/MRI to detect regional nodal and distant metastases in inte…
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FDA approval · 2024-11-14FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) from Avyxa Pharma, LLC. This action updates the product’s lab…
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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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EMA approval · 2024-10-18EMA Authorised: Zytiga (abiraterone acetate) — Janssen-Cilag International N.V.
The EMA authorised Zytiga (abiraterone acetate) from Janssen-Cilag International N.V. for prostate cancer under accelerated assessment.
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FDA approval · 2024-10-18FDA Approved: ORGOVYX — Supplemental Application (Sumitomo Pharma America, Inc.)
The FDA approved a supplemental application for ORGOVYX (relugolix) submitted by Sumitomo Pharma America, Inc., resulting in changes to the …
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FDA approval · 2024-10-17FDA Approved: LEUPROLIDE ACETATE — Original Application (UBI Pharma Inc.)
FDA approves Leuprolide acetate under an Original Application, establishing a generic version by UBI Pharma Inc. for the listed indications.
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FDA approval · 2024-08-02FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for Erleada (apalutamide) submitted by Janssen Products, LP. The supplemental submission is related …
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EMA approval · 2024-07-31EMA Authorised: Taxotere (docetaxel) — Sanofi Winthrop Industrie
The EMA authorised Taxotere (docetaxel) for multiple cancer indications including head and neck cancer, non-small cell lung cancer, gastric …
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FDA approval · 2024-03-19FDA Approved: BICALUTAMIDE — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Bicalutamide submitted by Accord Healthcare Inc.
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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 · 2023-12-04FDA Approved: LUPRON DEPOT — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT (leuprolide acetate) from AbbVie, updating the product's label under a supplemental…
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FDA approval · 2023-11-17FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)
FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc., resulting in updated labeling f…
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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) from Astellas Pharma US, expanding its approved indication for prostate ca…
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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 · 2023-09-19FDA Approved: DOCETAXEL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal's supplemental application to manufacture and market a generic docetaxel, enabling its supply for cancer treatment i…
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FDA approval · 2023-09-15FDA Approved: DOCETAXEL — Supplemental Application (Gland Pharma Limited)
FDA approved a supplemental application for docetaxel from Gland Pharma Limited under an ANDA for the generic product.
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FDA approval · 2023-05-31FDA Approved: LYNPARZA — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for LYNPARZA (olaparib) from AstraZeneca Pharmaceuticals LP, resulting in changes to the product…
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FDA approval · 2023-03-30FDA Approved: ORGOVYX — Supplemental Application (Sumitomo Pharma America, Inc.)
The FDA approved a supplemental application for ORGOVYX (relugolix) submitted by Sumitomo Pharma America, expanding the labeling for the dru…
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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…