Breast Cancer
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Sign up freeTop drugs studied for this disease
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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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EMA approval · 2024-07-30EMA Authorised: Fareston (toremifene) — Orion Corporation
The European Medicines Agency authorised Fareston (toremifene) by Orion Corporation for breast cancer, with the decision dated 26 July 2024.
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FDA approval · 2024-07-22FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Kisqali (ribociclib) submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2024-07-18FDA Approved: ERIBULIN MESYLATE — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original ANDA for eribulin mesylate, authorizing the generic manufacturing of this cancer drug.
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FDA approval · 2024-06-28FDA Approved: ERIBULIN MESYLATE — Original Application (HIKMA PHARMACEUTICALS USA INC.)
FDA approved a generic version of eribulin mesylate (ERIBULIN MESYLATE) from Hikma Pharmaceuticals USA Inc. as an Original Application (ANDA…
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FDA approval · 2024-06-18FDA Approved: HERCEPTIN HYLECTA — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) from Genentech, expanding/modifying i…
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EMA approval · 2024-06-06EMA Authorised: Myocet liposomal (previously Myocet) (doxorubicin hydrochloride) — CHEPLAPHARM Arzneimittel GmbH
EMA authorised Myocet liposomal (doxorubicin hydrochloride) for breast cancer, with CHEPLAPHARM Arzneimittel GmbH as the marketing authorisa…
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FDA approval · 2024-05-06FDA Approved: CERIANNA — Supplemental Application (GE Healthcare Inc.)
FDA approved a supplemental application for CERIANNA (fluoroestradiol F-18) from GE Healthcare Inc. The action updates the product's approva…
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FDA approval · 2024-04-24FDA Approved: VIJOICE — Original Application (Novartis Pharmaceuticals Corporation)
The FDA approved the original application for VIJOICE (alpelisib) by Novartis for adult patients with HR-positive, HER2-negative advanced or…
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FDA approval · 2024-04-15FDA Approved: CAPECITABINE — Supplemental Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s supplemental application for Capecitabine, updating regulatory status for this cancer drug. The action lik…
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FDA approval · 2024-04-05FDA Approved: ERIBULIN MESYLATE — Original Application (Gland Pharma Limited)
FDA approved an original (generic) application for Eribulin Mesylate from Gland Pharma Limited, authorizing the generic version of the produ…
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FDA approval · 2024-03-21FDA Approved: FULVESTRANT — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application from Amneal Pharmaceuticals LLC for Fulvestrant (generic), under ANDA210044, indicating approval…
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FDA approval · 2024-03-07FDA Approved: TALZENNA — Original Application (U.S. Pharmaceuticals)
FDA approves TALZENNA (talazoparib) in the original application for the treatment of adult patients with germline BRCA-mutated, HER2-negativ…
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FDA approval · 2024-03-05FDA Approved: CAPECITABINE — Original Application (BluePoint Laboratories)
The FDA approved the original application for capecitabine by BluePoint Laboratories, enabling a generic version of the cancer drug.
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FDA approval · 2023-11-09FDA Approved: ORSERDU — Supplemental Application (Stemline Therapeutics, Inc.)
The FDA approves a supplemental application for ORSERDU (elacestrant) submitted by Stemline Therapeutics, Inc.
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FDA approval · 2023-10-23FDA Approved: CAPECITABINE — Original Application (Teyro Labs Private Limited)
FDA approved the original application (ANDA) for a generic capecitabine product manufactured by Teyro Labs Private Limited.
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FDA approval · 2023-10-02FDA Approved: OGIVRI — Supplemental Application (Biocon Biologics Inc.)
FDA approved a supplemental Biologics License Application for OGIVRI (trastuzumab-dkst) from Biocon Biologics Inc. The biosimilar is intende…
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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 · 2023-09-06FDA Approved: IBRANCE — Supplemental Application (U.S. Pharmaceuticals)
The FDA approved a supplemental application for IBRANCE (palbociclib) submitted by U.S. Pharmaceuticals.
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FDA approval · 2023-08-24FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to co-pack Kisqali (ribociclib) with Femara (letrozole), enabling a single package for combination t…
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FDA approval · 2023-07-25FDA Approved: TAMOXIFEN CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Tamoxifen citrate from Mylan Pharmaceuticals Inc., solidifying its generic product approval.
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FDA approval · 2023-07-10FDA Approved: CAPECITABINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for capecitabine from Teva Pharmaceuticals USA, Inc., indicating an update to its labeling or in…
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FDA approval · 2023-06-30FDA Approved: FULVESTRANT — Original Application (Eugia US LLC)
FDA approved the original application for Fulvestrant (generic) from Eugia US LLC. Fulvestrant is used to treat hormone receptor-positive me…
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FDA approval · 2023-06-20FDA Approved: TALZENNA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for TALZENNA (talazoparib) from Pfizer Laboratories Div Pfizer Inc.