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FDA Priority
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Merck Secured Priority Review Status From The Us FDA for an Investigational Solution
Nov 20, 2013Merck has secured priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of its antifungal agent, Noxafil (posaconazole), ...
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Eli Lilly and Company Has Received Priority Review Status From The FDA
Oct 25, 2013Eli Lilly and Company has received priority review status from the US Food and Drug Administration (FDA) for its ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial ...
Tags: Cancer Drug, FDA Priority
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Bayer and Onyx Have Announced FDA Priority Review Designation
Aug 29, 2013Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar ...
Tags: New Drug Application, FDA
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Genentech Obtained FDA Priority Review Status for GA101 to Treat CLL
Jul 5, 2013Genentech, a member of the Roche Group, has obtained FDA priority review status for Obinutuzumab (GA101) to treat previously untreated chronic lymphocytic leukemia (CLL). The FDA has also accepted the company's biologics license ...
Tags: Genentech, FDA Priority
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Gilead Obtained Priority Review Status for Sofosbuvir New Drug Application
Jun 13, 2013Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
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Celgene International Has Obtained FDA Priority Review Status for Abraxane
May 24, 2013Celgene International has obtained FDA priority review status for Abraxane (paclitaxel protein-bound particles for injectable suspension) supplemental new drug application (sNDA). The application covers the use of Abraxane and gemcitabine ...
Tags: Celgene sNDA, FDA Priority
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The USFDA Has Granted Priority Review Designation to ViiV Healthcare's Dolutegravir
Feb 19, 2013The USFDA has granted priority review designation to ViiV Healthcare's dolutegravir as a candidate with the potential to treat HIV infection in combination with other antiretroviral agents, in adolescents and adults. The dolutegravir new ...
Tags: infection therapy, Healthcare, FDA
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GSK Gained FDA Priority Review Status for The Supplemental New Drug Application
Dec 7, 2012GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection. ...
Tags: GlaxoSmithKline, GSK, promacta, thrombocytopenia
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US FDA Has Accepted Thrombogenics'biologics License Application
Nov 28, 2012The US FDA has accepted ThromboGenics'biologics license application for ocriplasmin intravitreal injection,2.5mg/ml and granted it priority review. The company proposed the injection for the treatment of symptomatic Vitreomacular ...
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Janssen Research and Development Has Received The Priority Review
Aug 30, 2012Janssen Research and Development has received the Priority Review for the supplemental New Drug Application (sNDA) for ZYTIGA from US Food and Drug Administration (FDA). Zytiga (abiraterone acetate) is administered in combination with ...
Tags: sNDA, priority review, FDA
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Sanofi and Regeneron Pharmaceuticals Received FDA Priority Review for The BLA of ZALTRAP
Apr 6, 2012Sanofi and Regeneron Pharmaceuticals have received FDA priority review for the biologics license application (BLA) of ZALTRAP (aflibercept) as a treatment for metastatic colorectal cancer (mCRC). The filing was based on the Phase III ...
