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Clinical Hold on RAPT Zelnecirnon Studies

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A report of a patients liver failure leads to an FDA clinical hold against two RAPT Therapeutics Phase 2 trials involving zelnecir...

Why Industry Resists FDA Quality Management Efforts

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PDC Pharma Strategy CEO Penelope Przekop says there are several reasons why the drug industry is not rapidly moving toward quality...

Comments Extended on Master Protocols Guide

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Federal Register notice: FDA extends the comment period on a 12/22 notice for its Master Protocols for Drug and Biological Product...

Iovance Melanoma Cell Therapy Approved

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FDA grants accelerated approval to Iovance Biotherapeutics for Amtagvi, a cellular therapy indicated for treating certain adult pa...

sBLA for Elevidys Conversion to Traditional Approval

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FDA accepts for priority review a Sarepta Therapeutics supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to conver...

Xolair Approved for Reducing Allergic Reactions

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FDA approves a Novartis supplemental BLA for Xolair (omalizumab) for reducing allergic reactions related to accidental exposure to...

Metabolic Disease Panel Notice Amended

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Federal Register notice: FDA amends a 12/12/2023 notice requesting nominations for voting members to serve on CDERs Genetic Metabo...

Gilead Sciences Pauses Magrolimab Studies

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Gilead Sciences pauses enrollment globally in its magrolimab solid tumor studies and FDA subsequently requests (XXX TENSE XXX) a p...

CDRH Product Evaluation Head Maisel Retiring

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CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel announces he will retire this spring.

ANDA Product-Specific Guidances Added

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Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances on the design of bi...