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Breast Cancer News (Page 15)
Related terms: Breast Cancer, inflammatory, Cancer, Breast, Carcinoma, Ductal, Carcinoma, Lobular, Ductal Carcinoma in Situ (DCIS), Ductal Carcinoma in Situ, DCIS
FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
INCHEON, South Korea & JERUSALEM--(BUSINESS WIRE) December 14, 2018 --Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has...
FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected...
Kisqali (ribociclib) Approved for Additional Indications in HR+/HER2- Advanced Breast Cancer
Basel, July 18, 2018 - Novartis today announced a new approval for Kisqali (ribociclib) from the US Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth...
Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer
INDIANAPOLIS, Feb. 26, 2018 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) in combination with...
FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer
January 12, 2018 – The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that...
FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer
South San Francisco, CA – December 20, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Perjeta ® ...
FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
December 1, 2017 – The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic...
FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
September 28, 2017 – The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor...
Faslodex (fulvestrant) Receives FDA Approval as Monotherapy for Expanded Use in HR+, HER2- Advanced Breast Cancer
August 28, 2017 – AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Faslodex (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor...
FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
July 17, 2017 – The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type...
Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer
March 31, 2017 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin...
FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer
Basel, March 13, 2017 - The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based...
Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer
Friday, February 19, 2016 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib) 125mg...
Teikoku Pharma USA, Inc. Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula
San Jose, Calif. - December 28, 2015 - Teikoku Pharma USA (TPU) announced today that the U.S. Food and Drug Administration ("FDA") has approved Docetaxel Injection, Non-Alcohol Formula ("Docetaxel...
FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer
February 3, 2015 – The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer. Breast cancer in women is the...
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Breast Cancer, Metastatic, Breast Cancer - Adjuvant, Cancer
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methotrexate, fluorouracil, anastrozole, letrozole, Arimidex, Herceptin, Keytruda, Femara, trastuzumab, tamoxifen, Ibrance