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Sanofi and Regeneron announce regulatory and clinical update for Zaltrap® (aflibercept)
5 April 2012 | By Sanofi
The FDA has granted Priority Review of the BLA for the investigational agent Zaltrap®...
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Food and Drug Administration (FDA)
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Efficacy and safety data for ZOSTAVAX®
2 April 2012 | By Merck
Merck announced that data from the pivotal Phase III study with ZOSTAVAX® in adults ages 50 to 59 were published in the April 1 issue of Clinical Infectious Diseases...
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US court denies preliminary injunction application against the FDA
26 March 2012 | By AstraZeneca
The US District Court for the District of Columbia issued an opinion and order in AstraZeneca’s lawsuit...
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Update on FDA Advisory Committee vote on investigational medicine Ridaforolimus
20 March 2012 | By Merck
"Merck remains confident in the potential of the investigational agent ridaforolimus..."
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GSK announces positive vote from FDA panel for pazopanib in certain advanced soft tissue sarcomas
20 March 2012 | By GlaxoSmithKline
“Treatment options for patients with advanced soft tissue sarcoma are limited..."
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FDA approves first Boniva generics to treat or prevent osteoporosis
19 March 2012 | By FDA
The U.S. FDA approved the first generic versions of Boniva (ibandronate) tablets...
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Alcon gains exclusive ex-US rights for ocriplasmin
16 March 2012 | By Novartis
Potential first pharmacological treatment for symptomatic vitreomacular adhesion...
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Sanofi to acquire Pluromed, Inc., expanding its presence in biosurgery
16 March 2012 | By Sanofi
Sanofi and Pluromed Inc. have entered into a definitive agreement under which Sanofi is to acquire Pluromed Inc...
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AstraZeneca files lawsuit against the FDA for decision regarding quetiapine product labelling and exclusivity
13 March 2012 | By AstraZeneca
AstraZeneca will vigorously defend its legal rights...
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FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling
9 March 2012 | By AstraZeneca
The FDA denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labelling...
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Abbott’s new FreeStyle InsuLinx Blood Glucose Monitoring System receives FDA clearance
8 March 2012 | By Abbott
U.S. FDA clearance for the FreeStyle InsuLinx Blood Glucose Monitoring System...
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Absolute Pro® Vascular Self-Expanding Stent System receives FDA approval
7 March 2012 | By Abbott
The U.S. FDA approved the Absolute Pro® Vascular Self-Expanding Stent System...
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Merck provides U.S. regulatory update on investigational ezetimibe/atorvastatin tablets
5 March 2012 | By Merck
The U.S. FDA has issued a Complete Response Letter regarding Merck's NDA...
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FDA approves first four-strain flu vaccine
1 March 2012 | By AstraZeneca
MedImmune, has received approval from the US FDA for FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) in the prevention of influenza...
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Genzyme begins shipping Fabrazyme from newly approved Framingham manufacturing plant
1 March 2012 | By Sanofi
Genzyme has begun shipping Fabrazyme® (agalsidase beta)...
