Breast Cancer
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-09-16FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Kisqali (ribociclib) submitted by Novartis, resulting in changes to the product labeling and…
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FDA approval · 2025-09-16FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to allow a Kisqali (ribociclib) and Femara (letrozole) co-pack, enabling combined packaging for the …
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FDA approval · 2025-09-16FDA Approved: IBRANCE — Supplemental Application (U.S. Pharmaceuticals)
FDA approved a supplemental application for IBRANCE (palbociclib) submitted by U.S. Pharmaceuticals.
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EMA approval · 2025-08-29EMA Authorised: Talzenna (talazoparib) — Pfizer Europe MA EEIG
The EMA authorised Talzenna (talazoparib) for breast cancer. The marketing authorization holder is Pfizer Europe MA EEIG.
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EMA approval · 2025-08-21EMA Authorised: Trodelvy (sacituzumab govitecan) — Gilead Sciences Ireland UC
EMA authorised Sacituzumab govitecan (Trodelvy) for breast cancer, including triple-negative breast cancer, on 5 June 2025, with Gilead Scie…
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FDA approval · 2025-08-21FDA Approved: TRAZIMERA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for TRAZIMERA (trastuzumab-qyyp) from Pfizer Laboratories Div Pfizer Inc, authorizing changes under …
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FDA approval · 2025-08-15FDA Approved: LETROZOLE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for letrozole tablets submitted by Chartwell RX, LLC (a generic letrozole product).
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EMA approval · 2025-08-12EMA Authorised: Naveruclif (paclitaxel) — Accord Healthcare S.L.U.
EMA authorised Naveruclif (paclitaxel) by Accord Healthcare S.L.U. for breast cancer, pancreatic cancer, and non-small cell lung cancer.
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FDA approval · 2025-08-05FDA Approved: ERIBULIN MESYLATE — Original Application (Kindos Pharmaceuticals Co., Ltd.)
FDA approves an original application for Eribulin Mesylate from Kindos Pharmaceuticals Co., Ltd., enabling its generic product to enter the …
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EMA approval · 2025-08-04EMA Authorised: Docetaxel Kabi (docetaxel) — Fresenius Kabi Deutschland GmbH
The EMA authorised Docetaxel Kabi (docetaxel) from Fresenius Kabi Deutschland GmbH for multiple cancer indications, including head and neck …
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FDA approval · 2025-07-28FDA Approved: KISQALI — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Kisqali (ribociclib) submitted by Novartis Pharmaceuticals Corporation, authorizing an updat…
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FDA approval · 2025-07-28FDA Approved: KISQALI FEMARA CO-PACK — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to offer a Kisqali (ribociclib) and letrozole (Femara) co-pack, enabling concurrent dispensing of th…
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FDA approval · 2025-07-24FDA Approved: EXEMESTANE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Exemestane from Aurobindo Pharma Limited, authorizing a generic version of Exemestane in the…
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FDA approval · 2025-07-24FDA Approved: EXEMESTANE — Supplemental Application (Florida Pharmaceutical Products, LLC)
The FDA approved a supplemental application for Exemestane submitted by Florida Pharmaceutical Products, LLC. Exemestane is an aromatase inh…
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FDA approval · 2025-07-22FDA Approved: VIJOICE — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for VIJOICE (alpelisib) from Novartis Pharmaceuticals Corporation.
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FDA approval · 2025-07-15FDA Approved: ANASTROZOLE — Supplemental Application (Natco Pharma Limited)
The FDA approved a supplemental application for ANASTROZOLE by Natco Pharma Limited, issuing regulatory approval for a generic version of an…
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FDA approval · 2025-07-03FDA Approved: ERIBULIN MESYLATE — Original Application (Dr. Reddys Laboratories Inc)
FDA approves Dr. Reddy's Laboratories' original ANDA for eribulin mesylate, a generic version of the anticancer agent.
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FDA approval · 2025-07-02FDA Approved: LETROZOLE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Letrozole submitted by Aurobindo Pharma Limited.
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FDA approval · 2025-07-01FDA Approved: EXEMESTANE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for Exemestane submitted by Cipla USA Inc.
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CLINICAL_TRIALS approval · 2025-06-26Clinical Trial Update: Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
Regulatory update noting that tucatinib in combination with capecitabine and trastuzumab has been approved for marketing in unresectable, pr…
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EMA approval · 2025-06-19EMA Authorised: Pazenir (paclitaxel) — ratiopharm GmbH
Pazenir (paclitaxel) has been authorised by EMA for use in breast cancer, with ratiopharm GmbH as the Marketing Authorisation Holder.
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FDA approval · 2025-06-17FDA Approved: CAPECITABINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Capecitabine filed by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2025-06-16FDA Approved: EXEMESTANE — Supplemental Application (Upsher-Smith Laboratories, Inc.)
The FDA approved a supplemental application for Exemestane submitted by Upsher-Smith Laboratories, Inc.
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FDA approval · 2025-06-12FDA Approved: TALZENNA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for TALZENNA (talazoparib) by Pfizer Laboratories Div Pfizer Inc.
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EMA approval · 2025-06-10EMA Authorised: Apexelsin (paclitaxel) — Whiteoak Pharmaceutical B.V.
The EMA authorised Apexelsin (paclitaxel) for breast cancer, pancreatic cancer, and non-small cell lung cancer, with Whiteoak Pharmaceutical…