Prostate Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-07-24FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc.
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FDA approval · 2017-05-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for leuprolide acetate from Sandoz Inc, authorizing an update related to this product.
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FDA approval · 2017-05-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)
FDA approved a supplemental application for leuprolide acetate from Meitheal Pharmaceuticals Inc, related to the existing approval for this …
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CLINICAL_TRIALS approval · 2017-03-24Clinical Trial Update: Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Regulatory approval has been granted for abiraterone acetate (Zytiga) for advanced prostate cancer, indicating marketing authorization for t…
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FDA approval · 2017-01-24FDA Approved: AXUMIN — Supplemental Application (Blue Earth Diagnostics)
The FDA approved a supplemental application for AXUMIN (fluciclovine F-18) submitted by Blue Earth Diagnostics.
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CLINICAL_TRIALS approval · 2017-01-20Clinical Trial Update: Detecting Recurrent Prostate Cancer With C-11 Choline Positron Emission Tomography: An Expanded Access Study
Marketing approval has been granted for the PET radiotracer [11C]Choline (C-11 Choline) to detect recurrent prostate cancer, based on data f…
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FDA approval · 2017-01-13FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
The FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA PHARMACEUTICALS, INC., resulting in label…
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FDA approval · 2016-12-19FDA Approved: AXUMIN — Supplemental Application (Blue Earth Diagnostics)
The FDA approved a supplemental application for AXUMIN (fluciclovine F-18) submitted by Blue Earth Diagnostics.
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FDA approval · 2016-10-20FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc.
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FDA approval · 2016-07-15FDA Approved: NILUTAMIDE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original application for the generic drug nilutamide.
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FDA approval · 2016-07-14FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) filed by Astellas Pharma US, Inc.
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FDA approval · 2016-06-21FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)
FDA approved a supplemental application for Firmagon (degarelix) submitted by Ferring Pharmaceuticals Inc.
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FDA approval · 2016-05-27FDA Approved: AXUMIN — Original Application (Blue Earth Diagnostics)
The FDA approves AXUMIN (fluciclovine F-18) in an original application for PET imaging to detect recurrent prostate cancer, with Blue Earth …
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FDA approval · 2016-05-10FDA Approved: BICALUTAMIDE — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for bicalutamide, authorizing changes to the product's labeling.
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FDA approval · 2016-02-29FDA Approved: VABRINTY — Supplemental Application (URONOVA PHARMACEUTICALS, INC.)
FDA approved a supplemental application for VABRINTY (leuprolide acetate) submitted by URONOVA Pharmaceuticals.
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FDA approval · 2016-01-22FDA Approved: XOFIGO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for XOFIGO (radium Ra-223 dichloride) from Bayer HealthCare Pharmaceuticals, updating its labeling/i…
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FDA approval · 2016-01-12FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)
The FDA has approved a supplemental application for Firmagon (degarelix) filed by Ferring Pharmaceuticals Inc. This approval represents an u…
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FDA approval · 2015-11-06FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental NDA for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc., to update the labeling and/or expand an ind…
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FDA approval · 2015-10-27FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)
The FDA approved a supplemental application for Firmagon (degarelix) submitted by Ferring Pharmaceuticals Inc.
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FDA approval · 2015-10-01FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc., reflecting an updated indication/la…
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FDA approval · 2015-08-18FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for ZYTIGA (abiraterone acetate) submitted by Janssen Biotech, Inc.
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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…
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FDA approval · 2015-07-31FDA Approved: FIRMAGON — Supplemental Application (Ferring Pharmaceuticals Inc.)
FDA approved a supplemental application for Firmagon (degarelix) submitted by Ferring Pharmaceuticals Inc.
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FDA approval · 2015-06-01FDA Approved: MITOXANTRONE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for mitoxantrone hydrochloride, submitted by Fresenius Kabi USA, LLC.
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FDA approval · 2015-05-20FDA Approved: ZYTIGA — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for ZYTIGA (abiraterone acetate) submitted by Janssen Biotech, Inc.