on February 13, 2015, for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.īristol-Myers Squibb Company announced the FDA has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.
announced that the FDA approved Lenvima (lenvatinib), the company's multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to two or more therapies indicated for the treatment of multiple sclerosis.Įisai Inc. The FDA approved Zinbryta (daclizumab), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis, Biogen and AbbVie announced.
Genentech announced that the FDA granted accelerated approval to Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The product is expected to be commercially available this summer and is recommended for use as part of a complete treatment program including counseling and psychosocial support. The Probuphine subdermal implant, which utilizes Titan's proprietary ProNeura technology, delivers buprenorphine continuously for up to six months. announced that the FDA has approved Probuphine (buprenorphine) implant for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8mg or less a day of oral buprenorphine. Ocaliva is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine and a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. announced that the FDA has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Netspot is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the U.S. Netspot received approval following a Priority Review from the FDA. Learn more about the cobas EGFR Mutation Test v2Īdvanced Accelerator Applications announced that the FDA has approved Netspot (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients. Roche announced that the FDA has approved the cobas EGFR Mutation Test v2 for use with plasma samples, as a companion diagnostic for the non-small cell lung cancer therapy Tarceva (erlotinib). announced that the FDA has approved Axumin (fluciclovine F 18) injection, a molecular imaging agent indicated for use in positron emission tomography imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen following prior treatment.
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