Breast Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-06-10FDA Approved: EXEMESTANE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Exemestane from Zydus Pharmaceuticals USA Inc., updating an existing approved product.
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FDA approval · 2025-06-09FDA Approved: ERIBULIN MESYLATE — Original Application (Sandoz Inc)
The FDA approved Sandoz's original ANDA for ERIBULIN MESYLATE, authorizing the generic product's marketing in the United States.
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EMA approval · 2025-06-03EMA Authorised: Ibrance (Palbociclib) — Pfizer Europe MA EEIG
The EMA authorised palbociclib (Ibrance) for breast cancer under Pfizer Europe MA EEIG. The decision date is 06 March 2025.
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EMA approval · 2025-05-23EMA Authorised: Nerlynx (neratinib) — Pierre Fabre Medicament
The European Medicines Agency authorised Nerlynx (neratinib) for breast cancer indications, under the marketing authorization holder Pierre …
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FDA approval · 2025-05-22FDA Approved: HERZUMA — Supplemental Application (Cephalon, Inc.)
FDA approved a supplemental application for Herzuma (trastuzumab) from Cephalon, Inc.
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FDA approval · 2025-05-15FDA Approved: PACLITAXEL PROTEIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (ALBUMIN-BOUND) — Original Application (BluePoint Laboratories)
FDA approved the original application for paclitaxel protein-bound particles for injectable suspension (albumin-bound) from BluePoint Labora…
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EMA approval · 2025-05-15EMA Authorised: Faslodex (fulvestrant) — AstraZeneca AB
The EMA authorised Faslodex (fulvestrant) for breast cancer under the marketing authorisation holder AstraZeneca AB, decision dated 14 May 2…
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FDA approval · 2025-05-14FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)
A supplemental application for KADCYLA (ado-trastuzumab emtansine) submitted to the FDA by Genentech, Inc.
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EMA approval · 2025-05-13EMA Authorised: Kanjinti (trastuzumab) — Amgen Europe B.V.
The European Medicines Agency authorised Kanjinti (trastuzumab) by Amgen Europe B.V. for gastric and breast cancers.
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FDA approval · 2025-05-13FDA Approved: DOCETAXEL — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approves a generic docetaxel product under an original ANDA for Meitheal Pharmaceuticals Inc.
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EMA approval · 2025-05-05EMA Authorised: Capecitabine Accord (capecitabine) — Accord Healthcare S.L.U.
The EMA authorised Capecitabine Accord (capecitabine) by Accord Healthcare S.L.U. for breast cancer, colorectal cancer, and stomach cancer, …
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EMA approval · 2025-05-05EMA Authorised: Ecansya (previously Capecitabine Krka) (capecitabine) — Krka, d.d., Novo mesto
The EMA authorised Ecansya, a capecitabine product by Krka, as a new generic cancer treatment option for breast, colon, colorectal, and gast…
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EMA approval · 2025-05-02EMA Authorised: Xeloda (capecitabine) — CHEPLAPHARM Arzneimittel GmbH
The EMA authorised CHEPLAPHARM Arzneimittel GmbH to market Xeloda (capecitabine) in the EU for several cancers, including breast, colon/colo…
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FDA approval · 2025-04-23FDA Approved: IBRANCE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for IBRANCE (palbociclib) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2025-04-22FDA Approved: LETROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Letrozole from Teva Pharmaceuticals USA, Inc., updating the approved generic product under t…
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FDA approval · 2025-04-02FDA Approved: PERJETA — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for PERJETA (pertuzumab) submitted by Genentech, Inc.
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FDA approval · 2025-03-26FDA Approved: DEXRAZOXANE — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved a generic dexrazoxane (ANDA216748) from Novadoz Pharmaceuticals LLC under an original application.
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FDA approval · 2025-03-21FDA Approved: ANASTROZOLE — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for Anastrozole from Accord Healthcare Inc., representing a supplemental approval for this product. …
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FDA approval · 2025-03-04FDA Approved: ERIBULIN MESYLATE — Original Application (Sun Pharmaceutical Industries Limited)
FDA approved Sun Pharmaceutical Industries Limited's original ANDA for eribulin mesylate, confirming a generic version of the cancer drug. T…
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FDA approval · 2025-02-28FDA Approved: ONTRUZANT — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ONTRUZANT (trastuzumab) by Organon LLC. This document confirms the supplemental approval for the…
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FDA approval · 2025-02-18FDA Approved: ANASTROZOLE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for a generic version of anastrozole from Zydus Lifesciences Limited. The approval allows marketing …
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CLINICAL_TRIALS approval · 2025-02-14Clinical Trial Update: Margetuximab Expanded Access Program
Margetuximab has received marketing approval, advancing its expanded access program for HER2-positive breast cancer and other HER2-positive …
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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: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Kisqali (ribociclib) submitted by Novartis Pharmaceuticals Corporation, resulting in updated…
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FDA approval · 2025-02-11FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application to offer a Kisqali-Femara co-pack, combining ribociclib with letrozole. The co-pack is intended …