Prostate Cancer
📧 Sign up to get email alerts when something new happens for Prostate Cancer.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2023-03-03FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)
FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) submitted by Verity Pharmaceuticals Inc. to modify its labeling.
-
FDA approval · 2023-02-28FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
The FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) submitted by Avyxa Pharma, LLC.
-
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…
-
FDA approval · 2022-11-22FDA Approved: DOCIVYX — Original Application (Avyxa Pharma, LLC)
FDA approves DOCIVYX (docetaxel) under an original NDA submitted by Avyxa Pharma, LLC.
-
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.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2022-10-28FDA Approved: LEUPROLIDE ACETATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' original ANDA for Leuprolide acetate, a generic version of Lupron.
-
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…
-
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…
-
FDA approval · 2022-06-16FDA Approved: GALLIUM GA-68 PSMA-11 — Supplemental Application (UCLA Biomedical Cyclotron)
The FDA approved a supplemental application for Gallium-68 PSMA-11 (Gallium-68 Gozetotide) from UCLA Biomedical Cyclotron, updating its regu…
-
FDA approval · 2022-06-16FDA Approved: GALLIUM GA-68 PSMA-11 — Supplemental Application (UCSF Radiopharmaceutical Facility)
The FDA approved a supplemental application for Gallium-68 PSMA-11 (Gozetotide) from the UCSF Radiopharmaceutical Facility.
-
FDA approval · 2022-06-06FDA Approved: LEUPROLIDE ACETATE — Original Application (Eugia US LLC)
The FDA approved Eugia US LLC's generic Leuprolide Acetate under an Original Application (ANDA 212963), making a generic version of this med…
-
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…
-
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.
-
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…
-
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…
-
FDA approval · 2022-01-13FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc. The action reflects an approval …
-
FDA approval · 2022-01-13FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc., resulting in updated labeling for p…
-
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…
-
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…
-
FDA approval · 2021-12-01FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Dr. Reddys Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' supplemental application for abiraterone acetate, enabling a generic version of the cancer drug.
-
FDA approval · 2021-11-22FDA Approved: ABIRATERONE ACETATE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Abiraterone acetate from Apotex Corp. (generic).
-
FDA approval · 2021-11-17FDA Approved: GALLIUM GA-68 PSMA-11 — Supplemental Application (UCLA Biomedical Cyclotron)
The FDA approved a supplemental application for Gallium-68 PSMA-11 (gallium-68 gozetotide) from UCLA Biomedical Cyclotron, enabling continue…
-
FDA approval · 2021-11-17FDA Approved: GALLIUM GA-68 PSMA-11 — Supplemental Application (UCSF Radiopharmaceutical Facility)
The FDA approved a supplemental application for Gallium-68 PSMA-11 (Ga-68 Gozetotide), a PET radiopharmaceutical used to image prostate canc…
-
FDA approval · 2021-09-07FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for ERLEADA (apalutamide) from Janssen Products, LP, indicating an expanded authorization for the dr…
-
FDA approval · 2021-08-13FDA Approved: LEUPROLIDE ACETATE — Original Application (NorthStar RxLLC)
FDA approved the Leuprolide acetate original application (ANDA213829) for a generic version, issued to NorthStar RxLLC.