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NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.

FDA Weighs Black Box Warning on Covid Vaccines

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FDA considers adding a Boxed Warning to Covid-19 vaccines, the latest action as part of an ongoing campaign to scrutinize and rest...

Amgens Uplizna OKd for Generalized Myasthenia Gravis

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FDA approves Amgens Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis who test positive for anti-acetylcho...

FDA Gives Expedited Review for Lilly Obesity Pill

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Senior FDA officials urge agency reviewers to speed up the review of Eli Lillys NDA for its oral weight loss pill orforglipron aft...

Study Warns Drug Trials are Lacking Diversity

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A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clin...

FDA, Industry Debate America First User Fee Incentive

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FDA and drug-industry negotiators exchange early feedback on the agencys proposed America First fee incentives for domestic drug d...

FDA OKs Akeega for BRCA2-Mutated Metastatic Prostate Cancer

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FDA approves Janssens Akeega a fixed-dose combination of niraparib and abiraterone acetate with prednisone for adults with metas...

Exceptional Performance of TAP Pilot: Report

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An independent assessment of the FDA Total Product Lifecycle Advisory Program pilot finds it met its objectives exceptionally well...

FDA OKs 1st At-Home Stimulator for Depression

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FDA approves the first at-home, prescription-only brain-stimulation device to treat major depressive disorder.

Medical Device Recall Improvement Act Reintroduced

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Rep. Jan Schakowsky and Sen. Dick Durbin reintroduce their Medical Device Recall Improvement Act to improve medical device recall ...