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FDA Misses GSK Nucala for COPD Review Decision

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FDA again misses a user fee review action decision in the wake of mass staff cuts, the third miss in a month this time it's a GSK...

Odds Low for DTC Ad Ban: Conference Speakers

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Speakers at the DTC National conference suggest a ban on drug DTC ads is not very likely.

Gottlieb, McClellan Hit FDA Reorganization Plan

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Former FDA commissioners Scott Gottlieb and Mark McClellan voice concerns about an HHS proposed reorganization of FDA that would c...

FDA Ombudsman Recommends Stakeholder Education

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The FDA Office of Inspections and Investigations ombudsman program calls for establishing a dedicated Web page as a stakeholder ed...

Orchestra BioMeds Trial OKd on Sirolimus Balloon

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FDA approves an Orchestra BioMed IDE to begin a pivotal clinical trial evaluating its next generation Virtue Sirolimus-AngioInfusi...

Fast Track Awarded to Polycythemia Vera Drug

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FDA grants Italfarmaco a fast track designation to givinostat for treating patients with polycythemia vera, a rare hematologic can...

FDA Implementing AI-Assisted Scientific Review

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FDA commissioner Michael Makary says the agency is rolling out a generative AI-assisted scientific review tool to all Centers by 6...

Court Confirms FDA Drug Shortage Ruling was Valid

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A northern Texas judge rules in FDAs favor in a case challenging its decision last year to remove Eli Lillys weight loss and diabe...

SS Innovations Seeks De Novo on Surgical Robot

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SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system.

Inspection Disruptions Wont Rise to Covid Level: Expert

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Former CDER Office of Compliance director Don Ashley says inspection disruptions caused by recent FDA reductions in force will not...