Breast Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-04-06FDA Approved: CERIANNA — Supplemental Application (GE Healthcare Inc.)
The FDA approved a supplemental application for CERIANNA (fluoroestradiol F-18) from GE Healthcare Inc.
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FDA approval · 2022-04-05FDA Approved: VIJOICE — Original Application (Novartis Pharmaceuticals Corporation)
FDA approved VIJOICE (alpelisib) via an Original Application submitted by Novartis Pharmaceuticals Corporation.
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FDA approval · 2022-02-18FDA Approved: METHYLTESTOSTERONE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original application for methyltestosterone, making a generic methyltestosterone product available.
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FDA approval · 2022-02-02FDA Approved: KADCYLA — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for KADCYLA (ado-trastuzumab emtansine) submitted by Genentech, Inc., signaling an updated/expanded …
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FDA approval · 2022-01-21FDA Approved: IXEMPRA — Supplemental Application (R-Pharm US Operating, LLC)
The FDA approved a supplemental application for IXEMPRA (ixabepilone) submitted by R-Pharm US Operating, LLC. The action updates the product…
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FDA approval · 2022-01-14FDA Approved: CAPECITABINE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Capecitabine from Dr. Reddy's Laboratories Limited.
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FDA approval · 2021-12-10FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to approve a co-packaged formulation of KISQALI (ribociclib) with FEMARA (letrozole), enabling their…
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FDA approval · 2021-11-17FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approves a supplemental application for Exemestane by Mylan Pharmaceuticals Inc., expanding its regulatory approval.
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FDA approval · 2021-11-03FDA Approved: ISOSULFAN BLUE — Original Application (Meitheal Pharmaceuticals Inc.)
FDA approved Meitheal Pharmaceuticals' original application for Isosulfan Blue, a surgical dye used to identify sentinel lymph nodes during …
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FDA approval · 2021-10-25FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for Methotrexate by Hikma Pharmaceuticals USA Inc., enabling a new generic version of the drug.
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EMA approval · 2021-10-15First-in-class medicine to treat aggressive form of breast cancer
EMA announces a first-in-class medicine approved to treat an aggressive form of breast cancer.
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FDA approval · 2021-09-15FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Kisqali (ribociclib) from Novartis Pharmaceuticals Corporation, expanding its labeling for u…
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FDA approval · 2021-09-15FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to offer Kisqali (ribociclib) and Femara (letrozole) in a co-pack, enabling joint packaging for appr…
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FDA approval · 2021-09-09FDA Approved: TALZENNA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for TALZENNA (talazoparib) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2021-08-13FDA Approved: FULVESTRANT — Original Application (Northstar Rx, LLC,)
FDA approved a generic fulvestrant from Northstar Rx through an Original Application (ANDA 213553). This approval establishes a generic vers…
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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.
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FDA approval · 2021-07-29FDA Approved: FULVESTRANT — Original Application (Zydus Lifesciences Limited)
The FDA approved a generic fulvestrant product from Zydus Lifesciences Limited under an Original Application for the treatment of estrogen r…
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FDA approval · 2021-07-20FDA Approved: PIQRAY — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for PIQRAY (alpelisib) by Novartis, updating the label to include a new indication for HR-positive, …
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FDA approval · 2021-07-01FDA Approved: DOCETAXEL — Original Application (Gland Pharma Limited)
FDA approves Gland Pharma Limited's generic docetaxel as an Original Application, adding a new generic option for cancer chemotherapy.
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FDA approval · 2021-06-28FDA Approved: NERLYNX — Supplemental Application (Puma Biotechnology, Inc.)
FDA approves a supplemental application for Nerlynx (neratinib) from Puma Biotechnology, Inc.
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FDA approval · 2021-06-22FDA Approved: LETROZOLE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Letrozole submitted by Teva Pharmaceuticals USA, Inc. The approval concerns the generic drug…
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FDA approval · 2021-05-28FDA Approved: FULVESTRANT — Supplemental Application (Meitheal Pharmaceuticals Inc)
The FDA approved a supplemental application for fulvestrant from Meitheal Pharmaceuticals Inc.
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FDA approval · 2021-05-19FDA Approved: KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) — Supplemental Application (Cardinal Health 414, LLC)
FDA approved a supplemental application for the Kit for the Preparation of Lymphoseek (Technetium-99m Tilmanocept) to prepare Lymphoseek for…
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FDA approval · 2021-04-02FDA Approved: LETROZOLE — Supplemental Application (Accord Healthcare, Inc.)
The FDA approved a supplemental application granting approval for Accord Healthcare, Inc.'s generic letrozole product.
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FDA approval · 2021-03-19FDA Approved: FULVESTRANT — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for fulvestrant by Sandoz Inc. under ANDA 205935, representing a supplemental approval for a gen…