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U.S. FDA approved Astellas‘ new antifungal drug Cresemba

NCE ApprovalPharmacodia.com2015-03-06 00:00 Read   233

On Mar 6,2015, FDA approved isavuconazonium sulfate as an azole antifungal drug for the treatment of invasive aspergillosis and invasive mucormycosis.

FDA approved Novartis‘ new drug Farydak for the treatment of multiple myeloma

NCE ApprovalPharmacodia.com2015-02-23 00:00 Read   343

On Feb 23,2015, FDA approved Farydak (panobinostat) from Novartis for the treatment of multiple myeloma.Panobinostat is a novel, broad-spectrum histone deacetylase (HDAC) inhibitor with a new mechanism of blocking multiple histone deacetylase enzymes,leading to apoptosis of malignant cells while healthy cells not affected.

U.S. FDA approved Eisai‘s new drug Lenvima for the treatment of thyroid cancer

NCE ApprovalPharmacodia.com2015-02-13 00:00 Read   297

On Feb 13, 2015, U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).

U.S. approved Ibrance (Palbociclib) for the treatment of breast cancer.

NCE ApprovalPharmacodia.com2015-02-03 00:00 Read   230

On Feb 3, 2015, U.S. FDA granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer. Ibrance works by inhibiting cyclin-dependent kinases (CDK4/6), involved in promoting the growth of cancer cells. Ibrance is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy. It is to be used in combination with letrozole to treat certain kinds of breast cancer in postmenopausal women.