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Cancer News (Page 20)
Related terms: Carcinoma, Malignant Disease, Malignant Tumor
FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia
September 1, 2017 – The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express...
FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome
South San Francisco, CA – August 30, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia
August 30, 2017 – The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of...
FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
August 3, 2017 – The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML)...
FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
August 1, 2017 – The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a...
FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma
PRINCETON, N.J.--(BUSINESS WIRE) July 24, 2017 --Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy...
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...
FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers
South San Francisco, CA – June 22, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Rituxan...
FDA Medwatch Alert: Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
ISSUE: FDA issued warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. It is a violation of...
Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer
WALTHAM, MA, March 27, 2017 – Tesaro, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Zejula (...
FDA Grants Accelerated Approval to Lartruvo (olaratumab) for Advanced Soft Tissue Sarcoma
October 19, 2016 – The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS),...
FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
KENILWORTH, N.J.--(BUSINESS WIRE)--August 5, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma
May 18, 2016 – The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product...
FDA Medwatch Alert: Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter
[Posted 07/27/2015] ISSUE: Teva Parenteral Medicines announced a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of...
FDA Medwatch Alert: Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter
ISSUE: Teva Parenteral Medicines issued a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified...
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