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FDA Approves 'Next Generation' Actonel

[ Price : $8.95]

FDA approves a Warner Chilcott NDA for Atelvia delayed-release tablets, described as its next generation of Actonel (risedronate ...

MedImmune Begins Gastrointestinal Cancer Trial

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MedImmune begins a Phase 1 trial with MT111 in patients with advanced gastrointestinal cancers.

As FDA Faces New Threats, Parallels Seen with 1938

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Harvard author of a potent new FDA book Daniel Carpenter draws parallels between the beleaguered agency that won historic regulato...

BioSante Planning 2011 LibiGel NDA

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BioSante Pharmaceuticals says it is planning a 2011 NDA submission to FDA for its LibiGel testosterone treatment for female sexual...

FDA Looking for REMS Help

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FDA principal deputy commissioner Joshua Sharfstein says the agency can use pharmacy school help in learning how best to use the a...

Stem Cell Therapeutics End-of-Phase 2 Meeting Set

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FDA grants Stem Cell Therapeutics an end-of-Phase 2 meeting with FDA to review its NTx-265 clinical programs.

FDA Looking at New Carboplatin Dosing Risk

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FDA says it is considering a communication to oncologists and other healthcare professionals on a newly discovered risk of toxic o...

Comments Sought on Classifying OTC Drugs as GRASE

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Federal Register Notice: FDA seeks comments on additional criteria for classifying OTC drugs as generally recognized as safe and e...

Onyx Pharma Delays NDA on Multiple Myeloma Drug

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Onyx Pharmaceuticals says it will delay an NDA submission for its multiple myeloma drug carfilzomib based on an FDA request for mo...

Boehringer Ingelheim Scraps Female Libido Pill

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Boehringer Ingelheim says it has decided to discontinue developing its investigational compound flibanserin for treating hypoactiv...