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User Fee Negotiations Are Hung Up on America First Proposals

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Drug user fee negotiators confront lingering divisions over FDAs America First proposals and the structure of hiring commitments, ...

DoJ Supports Generic Drug Skinny Label Provision

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The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug skinny labels threatens to undermine ...

Rare Disease Developers Welcome FDA Guidance

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Rare disease drug developers and patient advocates are applauding a series of new guidance documents from FDA that bring long-awai...

Senate Committee Presses Pentagon Over FDA Import Exemptions

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The U.S. Senate Special Committee on Aging raises concerns about FDAs handling of foreign drug manufacturing violations and how th...

Ionis' Olezarsen Priority Review for Severe Hypertriglyceridemia

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FDA accepts for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia.

Lillys Oral GLP-1 Orforglipron Beats Oral Semaglutide in Trial

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Eli Lilly reports favorable efficacy data on its investigational oral GLP-1 receptor agonist orforglipron, showing significantly g...

Makary Defends Approval Standards and Prasads Role

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FDA commissioner Marty Makary defends the agencys scientific standards and personnel, particularly CBER director Vinay Prasad, ami...

FDA Grants Accelerated Approval to Zongertinib for Lung Cancer

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FDA awards Boehringer Ingelheim Pharmaceuticals an accelerated approval for Hernexeos (zongertinib) for certain adults with unrese...

FDA Eyes Reviewer Bonuses to Speed Reviews

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FDA prepares to roll out a new bonus program that will reward drug and biologic reviewers for completing high-quality reviews ahea...

FDA Emphasizes Confidentiality as Foundation of Public Trust, Innovation

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An FDA Voices post by FDA chief operating officer Barclay Butler says the agencys ability to uphold the gold standard of regulator...