home

U.S.FDA approved Odomzo (sonidegib) to treat basal cell carcinoma

NCE ApprovalPharmacodia.com2015-07-24 00:00 Read   357

On July 24, 2015, FDA approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. It works by inhibiting a molecular pathway, called the Hedgehog pathway, which is active in basal cell cancers. By suppressing this pathway, Odomzo may stop or reduce the growth of cancerous lesions.

U.S.FDA approved Rexulti (brexpiprazole) to treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder

NCE ApprovalPharmacodia.com2015-07-10 00:00 Read   832

On July 10, 2015, FDA approved Rexulti (brexpiprazole) to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).The drug was codeveloped by Lundbeck and Otsuka. And it will be launched in August.

FDA approved new antiplatelet drug Kengreal (Cangrelor) for the adult patients undergoing percutaneous coronary intervention (PCI)

NCE ApprovalPharmacodia.com2015-06-22 00:00 Read   642

On June 22,2015, FDA approved Kengreal(Cangrelor) for the adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.

U.S. FDA approved two new therapies for IBS-D.

NCE ApprovalPharmacodia.com2015-05-27 00:00 Read   424

On May 27, 2015, U.S. FDA approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

U.S. FDA approved Kythera for the reduction of localized submental fat

NCE ApprovalPharmacodia.com2015-04-29 00:00 Read   368

On Apr 29,2015, FDA approved Kybella (deoxycholic acid) for the reduction of localized submental fat.

The new drug Zafatek from Takeda approved by PMDA as the first orally once-weekly long-lasting drug for type 2 diabetes

NCE ApprovalPharmacodia.com2015-03-26 00:00 Read   507

On Mar 26,2015, Trelagliptin succinate from Takeda was approved by PMDA as a once-weekly long-lasting dipeptidyl peptidase-IV (DPP-4) inhibitor for the treatment of type 2 diabetes.

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.