Search Results for "Imatinib For Pah Nda Withdrawl"
Original Source: FDA to discuss imatinib for PAH
FDA's Cardiovascular and Renal Drugs Advisory Committee will meet on Sept. 14 to discuss an NDA from Novartis AG (NYSE:NVS; SIX:NOVN) for imatinib to treat pulmonary arterial hypertension (PAH). The PDUFA date is not disclosed. Novartis submitted the...
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Bcr Abl and Src Kinase Inhibitors
Chronic myeloid leukemia (CML) is characterized by the presence of the Philadelphia (Ph) chromosome, which results from a reciprocal translocation between the long arms of the chromosomes 9 and 22 t...
Chronic Myelocytic Leukemia CML
Chronic myelocytic leukemia is the resulting disease when neutrophil, basophil, eosinophil, and monocyte progenitors become cancerous. It is usually caused by the presence of the Philadelphia chromo...
Insulin like Growth Factor 1 Receptor IGF 1R
Although the insulin-like growth factor-1 receptor (IGF-1R) was first cloned in 1986, it was the success of targeted drugs such as trastuzumab and imatinib that tyrosine kinase inhibitors and growth...
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[News] Imatinib is exorbitantly priced despite protests
The leukaemia drug imatinib is the first BCR–ABL kinase inhibitor developed by the Swiss drug company Novartis, and is one of most expensive drugs on the market. Since its approval by the US Food an...
Pending EC decision: Imatinib Teva, imatinib mesilate, Opinion date: 18-Oct-2012
Pending EC decision: Imatinib Accord, imatinib, Opinion date: 25-Apr-2013
Pending EC decision: Imatinib Accord , imatinib, Opinion date: 25-Apr-2013
Pending EC decision: Imatinib Actavis, imatinib, Opinion date: 21-Feb-2013
Novartis withdraws imatinib MAA for PAH
Novartis AG (NYSE:NVS; SIX:NOVN) withdrew an MAA from EMA for imatinib to treat pulmonary arterial hypertension (PAH). The pharma, which submitted the application last February, said it made the decis...
Matching PubMed Articles
Imatinib Mesylate Does Not Increase Bone Volume In Vivo.
Imatinib mesylate is a tyrosine kinase inhibitor used in the management of disorders in which activation of c-Abl, PDGFR, or c-Kit signaling plays a critical role. In vitro, imatinib stimulates osteob...
AbstractAim:To investigate the pharmacokinetics of imatinib in Chinese chronic myelogenous leukemia (CML) patients.Methods:Fourty-six naïve Chinese CML patients treated with imatinib (400 and 600 mg...
A pharmacokinetic study in patients with gastrointestinal stromal tumors (GIST) suggested that imatinib plasma concentration may decrease following long-term exposure. We assessed changes in imatinib...
The safety profile of imatinib in CML and GIST: long-term considerations.
Imatinib mesylate is considered the standard first-line systemic treatment for patients with chronic myeloid leukaemia (CML) and gastrointestinal stromal tumour (GIST) by targeting BCR-ABL and c-KIT t...
Renal dysfunction in a renal transplant patient treated concurrently with cyclosporine and imatinib.
Imatinib mesylate has proven activity in treating locally advanced or metastatic gastrointestinal stromal tumors (GIST). Drug interactions are particularly concerning as imatinib is extensively metabo...