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Kidney Risk in OTC Weight Loss Drug Alli

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FDA approves labeling changes for Haleons OTC weight loss drug alli to warn of the rare risk of kidney injury associated with its ...

Fewer But Longer Drug Shortages: USP Report

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The United States Pharmacopoeia 2025 annual drug shortage report documents a reduction in the number of drug shortages but an incr...

Require In Vivo BE Test for Tafinlar ANDA: Petition

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A Windels Marx petition asks FDA not to approve any ANDA for dabrafenib mesylate using the 505(j)(2)(C) pathway that doesnt includ...

Plausibility Mechanism Guidance Needs Clarifications: Article

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A Health Affairs article discusses clarifications and revisions that it says are needed in an FDA draft guidance describing a plau...

Changes in HCEI Draft Guidance Noted

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Three Akin Gump attorneys highlight some changes in a 2026 FDA draft guidance on communicating healthcare economic information fro...

Comments Extended and Workshop Planned for Drug Repurposing

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FDA extends the comment period by 30 days for its request for information on drug repurposing for unmet medical needs.

FDA OKs Less-Frequent Dosing Schedule for Lillys Ebglyss

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FDA approves an expanded dosing regimen for Lillys atopic dermatitis treatment Ebglyss (lebrikizumab-lbkz), allowing certain patie...

FDA Cites Formulated Solutions Over Manufacturing, Quality

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FDA sends an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and...

Gilead/Merck Stop Trodelvy/Keytruda Study

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Gilead and Merck say they have discontinued the KEYNOTE-D46/EVOKE-03 study of Gileads Trodelvy and Mercks Keytruda as a treatment ...

CGMP Violations Found in Zydus Record Review

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FDA warns Indias Zydus Lifesciences Limited about CGMP violations in its manufacturing of finished drugs.