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FDA WEBVIEW CLOSED JULY 4TH WEEK

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...

Optical Melanoma Detection Device Reclassified

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Federal Register notice: FDA proposes to reclassify optical diagnostic devices for melanoma detection and electrical impedance spe...

Pfizer Submits Paxlovid NDA

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Pfizer submits an NDA to FDA for Paxlovid to treat Covid-19 patients at high risk for progression to serious illness.

Draft Guide on Clinical Outcome Assessments

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Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Selecting, Developing, or...

Partial Clinical Hold on Sanofi MS Drug Trial

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Sanofi says enrollment in a Phase 3 tolebrutinib trial has been paused due to an FDA partial clinical hold.

Micronor Not Withdrawn Over Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Janssen Pharmaceuticals Micronor (norethindrone tablets), indicated for preventing pr...

Stakeholders Suggest Changes to Ulcerative Colitis Drug Guidance

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Five drug companies recommend changes to an FDA draft guidance on developing drugs to treat ulcerative colitis.

Add Omicron BA.4/5 Component to Boosters: FDA

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FDA tells Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an o...

Regulatory Review Period for Horizons Tepezza

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Horizon Therapeutics Tepezz...

FDA Review Extended on Provention Bio BLA

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FDA extends by three months the review of a Provention Bio BLA for teplizumab, indicated for delaying progression to Stage 3 clini...