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FDA Expands Ibrance for Breast Cancer Maintenance

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FDA grants Pfizer expanded approval for Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy...

Drug Trial Demographic Info Reported

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FDA publishes a report summarizing demographic information from pivotal trials supporting 46 novel new drugs approved in 2025.

Nicotine Dependence NDA Gets Complete Response Letter

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FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.

Pharmaneek Inspection Form FDA-483 Out

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FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility i...

FDA Nixes Enforcement Action Against Whoop's Blood Pressure Feature

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FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about...

Expand Real-World Evidence Use in Drug Approvals: Article

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Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.

Jubilant HollisterStier CGMP Issues

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FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.

4 CGMP Violations in Huons Inspection

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FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.

FDA Leadership Upheaval Yields Uncertainty: Post

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A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.