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pCR May Not be Valid Rectal Cancer Endpoint: Study

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A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments ...

FDA Looking to Expand Project Orbis Outside Oncology

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FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding...

FDA Warns Firm Marketing Blood Pressure Estimator

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FDA warns Boston, MA-based Whoop that it is illegally marketing an unapproved medical device that estimates blood pressure, despit...

Anselamimab Trial Misses Primary Endpoint in Amyloidosis

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A Phase 3 clinical trial evaluating Alexions anselamimab for light chain amyloidosis fails to meet its primary endpoint, but shows...

New Orphan Product Grant Funding Opportunity

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FDA releases a funding opportunity for natural history studies to advance product development in rare diseases and conditions.

7 Observations in Natco Pharma FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.

Guide to Characterize Combination Cancer Drugs

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FDA publishes a draft guidance on characterizing the effects of some oncology drugs when used in combination with other drugs.

Fast Track Status for Zenith NUT Cancer Drug

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FDA grants Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT ca...

Reviewers Question Otsuka PTSD Drug Efficacy

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FDA medical reviewers question the demonstration of efficacy in an Otsuka NDA for a combination of Rexulti and Zoloft to treat PTS...

Partial Hold on Kezars Zetomipzomib Lifted

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FDA lifts a partial clinical hold against Kezar Life Sciences and its completed PORTOLA Phase 2a clinical trial evaluating zetomip...