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FDA Clears Lung Nodule AI Measurement Tool

[ Price : $8.95]

FDA clears a Nines 510(k) for the NinesMeasure, a lung nodule measurement tool built with artificial intelligence that is intended...

Multiple Drug, Medical Device Violations at Tarmac Products

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FDA warns Tarmac Products about multiple drug and medical device violations in its production of OTC drugs and wound dressing medi...

Stakeholder Suggestions for Upcoming Disease Progression Workshop

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Four stakeholders suggest ways FDA can improve an upcoming public workshop on disease progression models.

AbbVie NDA for Migraine Accepted for Review

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FDA accepts for review an AbbVie NDA for atogepant, an orally administered calcitonin gene-related peptide receptor antagonist for...

FDA Approves CRISPR Trial to Correct Sickle Cell Gene Defect

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FDA approves a four-year clinical trial using CRISPR gene editing to cure sickle cell disease.

Panelists Discuss Biosimilar Regulatory Standards Divergence

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Panelists at a conference debate the value of clinical efficacy studies to determine biosimilar bioequivalence.

Akebia Therapeutics NDA for Kidney-disease Anemia

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Akebia Therapeutics submits an NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor f...

HHS Semiannual Regulatory Agenda

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HHS publishes its semiannual regulatory agenda including six final rules and four completed actions from FDA.

5 Traits the Next FDA Commissioner Should Have: Sackner-Bernstein

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Former CDER associate director Jonathan Sackner-Bernstein lists five traits the Biden administration should want in an FDA commiss...

Biom Orphan Status for Angelman Syndrome Drug

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FDA grants Biom Therapeutics an orphan drug designation for BIO017 and its use in treating Angelman syndrome.