Breast Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-02-11FDA Approved: CAMCEVI — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental application for CAMCEVI (leuprolide) from Accord BioPharma, Inc., expanding regulatory approval for this long-ac…
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CLINICAL_TRIALS approval · 2025-01-17Clinical Trial Update: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation
Eli Lilly's RET inhibitor selpercatinib (Retevmo) has been approved for marketing to treat cancers driven by RET activation, including non-s…
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FDA approval · 2024-12-26FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approves Slate Run Pharmaceuticals' original application for CYCLOPHOSPHAMIDE FOR INJECTION, expanding the market for a generic cyclopho…
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FDA approval · 2024-12-20FDA Approved: IBRANCE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for IBRANCE (palbociclib) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2024-12-19FDA Approved: CYCLOPHOSPHAMIDE — Original Application (BluePoint Laboratories)
FDA approved BluePoint Laboratories' original ANDA for cyclophosphamide, establishing a generic version of the chemotherapy agent.
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FDA approval · 2024-12-16FDA Approved: ARIMIDEX — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ARIMIDEX (anastrozole) filed by ANI Pharmaceuticals, Inc.
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FDA approval · 2024-12-16FDA Approved: FEMARA — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for FEMARA (letrozole) from Novartis Pharmaceuticals Corporation, updating the labeling or indicatio…
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CLINICAL_TRIALS approval · 2024-12-16Clinical Trial Update: Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
Named patient use program for abemaciclib to treat metastatic breast cancer has been approved for marketing.
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FDA approval · 2024-12-16FDA Approved: EXEMESTANE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Exemestane from Mylan Pharmaceuticals, finalizing approval of a generic Exemestane product. …
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FDA approval · 2024-12-13FDA Approved: FARESTON — Supplemental Application (Kyowa Kirin, Inc.)
FDA approved a supplemental application for Fareston (toremifene citrate) submitted by Kyowa Kirin, Inc., indicating changes approved to the…
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FDA approval · 2024-11-22FDA Approved: PHESGO — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for PHESGO, the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf, submitted…
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FDA approval · 2024-11-14FDA Approved: LUTRATE DEPOT — Supplemental Application (Avyxa Pharma, LLC)
FDA approved a supplemental application for LUTRATE DEPOT (leuprolide acetate) from Avyxa Pharma, LLC. This action updates the product’s lab…
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FDA approval · 2024-11-13FDA Approved: OGIVRI — Supplemental Application (Biocon Biologics Inc.)
The FDA approved a supplemental application for OGIVRI (trastuzumab-dkst) from Biocon Biologics Inc.
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FDA approval · 2024-10-29FDA Approved: CYCLOPHOSPHAMIDE — Original Application (Nexus Pharmaceuticals, LLC)
FDA approved Nexus Pharmaceuticals, LLC to market a generic cyclophosphamide product under Original Application ANDA216783.
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FDA approval · 2024-10-23FDA Approved: JYLAMVO — Supplemental Application (SHORLA ONCOLOGY INC.)
The FDA approved a supplemental application for JYLAMVO (methotrexate) filed by SHORLA ONCOLOGY INC.
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FDA approval · 2024-10-17FDA Approved: LEUPROLIDE ACETATE — Original Application (UBI Pharma Inc.)
FDA approves Leuprolide acetate under an Original Application, establishing a generic version by UBI Pharma Inc. for the listed indications.
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EMA approval · 2024-10-16EMA Authorised: Mevlyq (Eribulin mesylate) — YES Pharmaceutical Development Services GmbH
The EMA authorised Mevlyq (eribulin mesylate) for breast cancer and liposarcoma, with marketing authorisation holder YES Pharmaceutical Deve…
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FDA approval · 2024-09-24FDA Approved: GEMCITABINE HYDROCHLORIDE — Supplemental Application (Teyro Labs Private Limited)
FDA approved a supplemental application for Gemcitabine hydrochloride from Teyro Labs Private Limited, authorizing continued approval of thi…
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FDA approval · 2024-09-17FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Kisqali (ribociclib) submitted by Novartis Pharmaceuticals Corporation, updating the drug's labe…
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FDA approval · 2024-09-17FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to co-pack Kisqali (ribociclib) with Femara (letrozole) in a single package for breast cancer treatm…
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EMA approval · 2024-09-16EMA Authorised: Bondronat (ibandronic acid) — Atnahs Pharma Netherlands B.V.
EU marketing authorisation granted to Bondronat (ibandronic acid) for hypercalcemia, breast cancer with bone metastases, and bone-related fr…
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FDA approval · 2024-09-03FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to authorize the Kisqali-Femara co-pack (ribociclib and letrozole) by Novartis, enabling combination…
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FDA approval · 2024-09-03FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Kisqali (ribociclib) from Novartis Pharmaceuticals Corporation.
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EMA approval · 2024-08-30EMA Authorised: Iasibon (ibandronic acid) — Pharmathen S.A.
EMA authorised Iasibon (ibandronic acid) for hypercalcemia, prevention of bone fractures, and cancer-related indications involving metastati…
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FDA approval · 2024-08-16FDA Approved: LAPATINIB — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva's original application for a generic version of lapatinib for HER2-positive breast cancer.