Trials & Filings
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August 27, 2009
Schering-Plough’s Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma, has been accepted for review by the EMEA.
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August 25, 2009
Protalix BioTherapeutics, Inc. received Fast Track Designation from the FDA for prGCD, a plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.
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August 20, 2009
Roche and InterMune have initiated a Phase IIb study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin).
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August 19, 2009
After a five-year Phase III study, Lilly has decided not to submit arzoxifene to regulatory authorities
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August 17, 2009
Novartis received approval from the FDA for Extavia (interferon beta-1b) for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations.
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August 12, 2009
The FDA has extended the action date by 90 days for its review of Prevnar 13
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August 11, 2009
Avanir's investigational drug Zenvia met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in a Phase III trial
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August 7, 2009
Sanofi Pasteur, the vaccine division of Sanofi-Aventis, has submitted a supplemental application to the FDA to license its influenza A/H1N1 2009 monovalent vaccine.
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August 6, 2009
Galapagos NV has successfully completed a Phase I trial of its drug candidate GLPG0259 for rheumatoid arthritis (RA).
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August 4, 2009
Amgen announced positive top-line results from a head-to-head trial evaluating denosumab vs. Zometa
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August 4, 2009
The FDA has approved Livalo, a statin developed by Kowa Research Institute and Kowa Pharmaceuticals America
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August 3, 2009
Bristol-Myers Squibb and AstraZeneca received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
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August 3, 2009
Genentech has received approval from the FDA for Avastin plus interferon-alfa for metastatic renal cell carcinoma, the most common type of kidney cancer.
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August 3, 2009
The FDA has issued a Complete Response letter to Savient Pharmaceuticals for its gout treatment Krystexxa
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July 31, 2009
AstraZeneca has submitted an NDA for Zactima, an NSCLC treatment
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211 - 225 of 604 results
