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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...

Advocates Urge Congress to Rein In FDA Review Uncertainty

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A rare disease advocacy group tells Congress to increase FDA oversight, warning that inconsistent use of regulatory flexibility an...

FDA OKs Dupixent For Allergic Fungal Rhinosinusitis

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FDA approves a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and ch...

Alert on Abiomed Heart Pumps

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FDA issues an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, w...

FDA Division of Applied Regulatory Science Releases Annual Report

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CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advance...