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Notice on Info Technology Plan Corrected

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Federal Register notice: FDA corrects a 9/19 notice entitled Food and Drug Administration Information Technology Strategy; Request...

Novartis Gains Approval of IV Cosentyx

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FDA approves Novartis intravenous Cosentyx (secukinumab) formulation for treating adults with psoriatic arthritis, ankylosing spon...

Senator Urges Justice Probe of Respironics

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Sen. Richard Blumenthal (D-CT) calls on the Justice Department to take action against Philips Respironics after a recent investiga...

FDA OKs Zoryve Cream Expanded Use

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FDA approves an Arcutis Biotherapeutics supplemental NDA to expand the indication for Zoryve (roflumilast) cream 0.3% for the topi...

Syndax Reports Positive Leukemia Data

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Syndax Pharmaceuticals says new positive data justifies stopping the pivotal AUGMENT-101 trial of revumenib in adult and pediatric...

FDAs Daunting Task to Tackle Misinformation: Califf

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FDA commissioner Robert Califf addresses the Reagan-Udall Foundation about its new report on misinformation and observes the agenc...

FDA Clears Home Hemoglobin Test

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FDA clears a Sanguina 510(k) for the AnemoCheck Home, a home-use hemoglobin test kit.

Panel Votes Down Amgens Confirmatory Study

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FDAs Oncologic Drugs Advisory Committee votes 10 to 2 that the CodeBreak 200 confirmatory study cannot be reliably interpreted as ...

Clinical Hold for Innate Lacutamab Trials

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FDA places a partial clinical hold on the Innate lacutamab IND to treat two forms of T-cell lymphoma following a patient death in ...

CDRH Marks 10 Years of Cybersecurity Program

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FDA touts the 10th anniversary of the CDRH cybersecurity program, highlighting several program achievements.