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FDA Approves Byetta New Indication, Labeling Safety Changes

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FDA approves Byetta as Type 2 diabetes monotherapy and approves new safety labeling information for it.

FDA Issues H1N1 Test Guidance

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FDA issues a guidance on information manufacturers should submit with an emergency use authorization requests for 2009 H1N1 influe...

FDA Clears SQI Diagnostics Rheumatoid Arthritis Test

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FDA clears a SQI Diagnostics 510(k) for the SQiDworks Diagnostics Platform and its multiplexed IgXPLEX rheumatoid arthritis (RA) a...

Info on Public Health Survey Sent to OMB

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Federal Register Notice: FDA submits a collection of information on its public health notification readership survey to the Office...

Dendreon Tries Again with Provenge

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Dendreon submits an amended BLA to FDA for its controversial prostate cancer drug Provenge.

FDA Complete Response on Bone Fracture Drug

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FDA issues GTx, Inc. a complete response letter on an NDA for toremifene 80 mg, indicated for reducing fractures in men with prost...

BIO Continues to Defend Lengthy Biosimilar Exclusivity

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BIO blasts GPhAs request to pull biosimilar legislation from healthcare reform unless it is significantly changed.

Abbott Sues Impax to Block Generic Tricor

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Abbott Laboratories and Laboratoires Fournier SA sue Impax Labs over an ANDA for Tricor (fenofibrate) 48 mg and 145 mg tablets tha...

Salesman Says He Pushed Off-label Risperdal

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A Janssen salesman says he encouraged doctors to prescribe Risperdal for unapproved uses.

Geron and FDA Develop Plan to Lift Clinical Hold

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Geron Corp. says FDA has endorsed its plan to lift an agency-ordered clinical hold involving the companys human embryonic stem cel...