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HHS Overreach Renews Calls for Independent FDA

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A Sidley law briefing examines HHSs unprecedented overreach during the Trump Administration, which has drawn increased interest in...

Exelixis NDA for Cabometyx/Opdivo Combination

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FDA approves an Exelixis NDA for Cabometyx (cabozantinib) in combination with Bristol Myers-Squibbs Opdivo (nivolumab) for treatin...

Ultragenyx Cleared for Gene Therapy Trial

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FDA gives the green light to Ultragenyx Pharmaceutical to begin a seamless single-protocol Phase 1/2/3 study of UX701, an investig...

Insys Founder Pays $5 Million Over Opioid Scheme

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NJ attorney general Gurbir S. Grewal announces a $5 million settlement with Insys Therapeutics founder John N. Kapoor to resolve a...

MDIC External Evidence Framework Open for Comments

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The Medical Device Innovation Consortium says it will receive comments for the next month on its External Evidence Methods Framewo...

Cell and Gene Therapy Product Manufacturing Considerations

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FDA issues a guidance to give manufacturers of licensed and investigational cellular and gene therapy products risk-based recommen...

sNDA for Esbriet in Lung Disease Gets Priority Review

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FDA accepts for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lu...

New Tobacco Products Applications Guide Withdrawn

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Federal Register notice: FDA withdraws a draft guidance entitled Applications for Premarket Review of New Tobacco Products.

Canon Aquilion Exceed CT System Cleared

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FDA clears a Canon Medical Systems 510(k) for the Aquilion Exceed LB CT system.