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FDA Denies Zydus Mephyton Petition

[ Price : $8.95]

FDA denies a Zydus petition asking it to take certain actions regarding new applications citing Mephyton as the reference-listed-d...

Orphan Drug Status for Verastems Copiktra

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FDA grants Verastem an orphan drug designation for Copiktra (duvelisib) for use in treating T-Cell lymphoma.

FDA Opens GDUFA Science and Research Web Page

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FDA debuts a Web page dedicated to FY 2018 GDUFA science and research outcomes.

Trump to Name Stephen Hahn FDA Commissioner: BioCentury

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BioCentury reports that President Trump will nominate MD Anderson Cancer Center chief medical officer Stephen Hahn to be the next ...

FDA Update on Ranitidine Contaminant Testing

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FDA says it is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patient...

Guide on Testing Blood for Hep C

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FDA makes available a final guidance entitled Further Testing of Donations that are Reactive on a Licensed Donor Screening Test fo...

Enzyme Replacement Therapy Guidance

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FDA issues a guidance to help sponsors develop and conduct nonclinical studies during development of investigational enzyme replac...

Turner Portable Fluoroscopy/X-Ray Device Cleared

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FDA clears a Turner Imaging Systems 510(k) for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device.

GSK, Innoviva sNDA for Trelegy Ellipta in Asthma

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GlaxoSmithKline and Innoviva submits a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta for...

J&J Settles Ohio Opioid Cases for $20.4 Million

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Reuters reports that Johnson & Johnson will pay two Ohio counties $20.4 million to resolve opioid crisis claims.