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More Conflict of Interest Transparency Needed: GAO

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The Government Accountability Office recommends that FDA take steps to publicly disclose how it resolves conflict of interest and ...

Meaning of Prasads Departure Debated

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Three experts express differing views on the reasons for and the impact of the departure of CBER director Vinay Prasad from FDA fo...

Race to the Bottom Generic Model Threatens Quality/Supply: Expert

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A Brookings commentary warns that intense price competition in the U.S. generic drug market is undermining manufacturing quality a...

Ocugen Reports Positive Phase 2 Data for Vision Loss Gene Therapy

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Ocugen announces positive 12-month results from a mid-stage clinical trial of its experimental gene therapy OCU410, aimed at treat...

ImmunityBio Warning Letter Over Misleading Promotion of Anktiva

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FDA sends a Warning Letter to ImmunityBio, citing misleading promotional claims about its cancer therapy Anktiva (nogapendekin alf...

Adventa Nintedanib Petition Granted, Denied

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FDA grants in part and denies in part an AdvantaPharma petition seeking specific requirements on ANDA holders for generic nintedan...

FDA Requires New Seizure Warning for Parkinsons Drugs

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FDA requires an updated safety warning for Parkinsons drug products containing carbidopa/levodopa due to their potential to cause ...

Pfizer, Valneva to File BLA for Lyme Disease Vaccine

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Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more ...

Legal Update Highlights FDAs Guide on 3 Year Exclusivity

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A legal update from Wilson Sonsini Goodrich & Rosati addresses FDAs release earlier this month of a draft guidance clarifying the ...

Priority Review for Ionis Alexander Disease Drug

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FDA grants a priority review to an Ionis Pharmaceuticals NDA for zilganersen, an experimental treatment for Alexander disease.