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Ventlab Recalls Faulty Manual Resuscitators

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Ventlab Corp. recalls 14,602 of its manual resuscitators because they have been found to potentially deliver little to no air/oxyg...

Phase 3 Trial Initiated in AL Amyloidosis Patients

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Millenium: The Takeda Oncology Co. initiates a Phase 3 clinical trial to evaluate an investigational oral proteasome inhibitor tog...

Location Changed for Endocrinologic Panel Meeting

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Federal Register Notice: FDA amends a notice of an 11/8 Endocrinologic and Metabolic advisory committee meeting to change the loca...

FDA Panel Mixed on Genzyme Cholesterol NDA

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee gives a mixed vote on Genzymes Kynamro (mipomersen sodium) for treating...

FDA Expands Indication on Sapien Transcatheter Heart Valve

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FDA expands the approved indication on Edwards Lifesciences Sapien Transcatheter Heart Valve to include patients with aortic valve...

Location Changed for Nonprescription Drugs Panel Meeting

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Federal Register Notice: FDA changes the location and contact name for a 11/9 meeting of the Nonprescription Drugs Advisory Commit...

Aeterna Zentaris to File NDA for Growth Hormone Deficiency

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Aeterna Zentaris presents positive data for its oral diagnostic test for adult growth hormone deficiency and plans an early 2013 N...

Biogen Idec MS Drug Review Time Extended

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FDA extends for three months its PDUFA review deadline for Biogen Idecs dimethyl fumarate for treating multiple sclerosis.

FDA Should Work with Industry on Study Data Standards: Sanofi

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Sanofi asks FDA to continue working with industry on many aspects of clinical study data standards.

ThromboGenics NDA for Eye Drug Approved

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FDA approves a ThromboGenics NDA for Jetrea, the first drug approved to treat an eye condition called symptomatic vitreomacular ad...