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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Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Selecting, Developing, or...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Micronor Not Withdrawn Over Safety/Efficacy: FDA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Five drug companies recommend changes to an FDA draft guidance on developing drugs to treat ulcerative colitis.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...

Califf Adds 2 Senior Officials to Leadership Team

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FDA commissioner Robert Califf taps former Johns Hopkins School of Medicine professor Namandj N. Bumpus as the agencys new chief s...

Sentators Urge FDA to Allow OTC Hearing Aids

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Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA) urge FDA to finalize a proposed rule on making certain hearing aids ava...