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FDA Denies Attorneys Simufilam Petition

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FDA denies as inappropriate a citizen petition asking it to halt two Cassava Sciences simufilam trials and investigate concerns ab...

Priority Review for Dupixent sBLA

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FDA approves for priority review a Sanofi sBLA for Dupixent to treat moderate-to-severe atopic dermatitis in children 6 months to ...

Feds Have Tools to Cut Drug Prices: Report

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Researchers from Harvard Medical School and the Engelberg Foundation call on the U.S. government to exercise its legal rights to o...

FDA Fast Track for Bayer Blood Thinner

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FDA grants Bayer a fast track designation for its investigational blood thinner asundexian (BAY2433334) its use as secondary preve...

Public Citizen Wants Gabapentin Scheduled

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Public Citizen asks FDA and the Drug Enforcement Administration to add gabapentin products to Schedule V of the Controlled Substan...

Panel Votes Down Single-Country Clinical Trial

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An FDA advisory committee votes 14 to 1 that Innovent Biologics and Eli Lillys China-developed me too checkpoint inhibitor sintili...

Compounding Center Sales Head Sentenced

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A Massachusetts federal judge sentences the former national sales director for the defunct New England Compounding Center to time ...

Califf Nomination Stalled: Report

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An Associated Press report says the nomination of Robert Califf to be FDA commissioner is in doubt due to opposition from both Dem...

Sanofis Enjaymo OKd for Cold Agglutinin Disease

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FDA approves a Sanofi BLA for Enjaymo (sutimlimab-jome) for decreasing the need for red blood cell transfusions due to hemolysis i...

Info Collection on Generic User Fee Program Revised

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Federal Register notice: FDA sends to OMB an information collection revision entitled Generic Drug User Fee Program.