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FDA Cites Pinnacle Biologics for Misleading Photofrin Promo Videos

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FDA sends an untitled letter to Pinnacle Biologics, citing promotional videos for cancer therapy Photofrin (porfimer sodium).

Trodelvy OKd for First-Line Triple-Negative Breast Cancer

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FDA approves Gilead Sciences Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally ad...

Agency Says Firm Submitted Invalid Data

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FDA says it will not accept medical device test data generated by CCIC Huatongwei International Inspection in China because the ag...

FDA Policymaking May Return to Normalcy: Former FDAers

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Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under ...

Cotton Introduces Bill Targeting Chinese-Made Medical Devices

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Sen. Tom Cotton (R-AR) introduces a bill that would require FDA to review and potentially recall Chinese-manufactured networked me...

CeleCor Completes NDA Submission for Heart Attack Drug

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CeleCor Therapeutics says it has submitted an NDA for Disaggpro (zalunfiban), an investigational treatment for ST-segment elevatio...

Drug Quality Assurance Inspections Up in 2025

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The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.

FDA Progressing Toward Replacing Animal Testing :Study

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A newly published commentary in the journal Stem Cell Research & Therapy says FDAs efforts to reduce reliance on animal testing is...

Antibody Impurity Guidance Needs Specificity: Comments

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Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.

Stakeholders Comment on AI-Enabled Trial Pilot

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Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.