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Fast Track Awarded to Polycythemia Vera Drug

[ Price : $8.95]

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.

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...

Michael Rogers Resigns from FDA

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CBS News reports that FDA associate commissioner for inspections and investigations Michael Rogers is retiring, frustrated over ch...

FDA Picks Booz Allens Walsh as AI Chief

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FDA taps former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information techn...

Teva/Alvotechs Interchangeable Stelara Biosimilar OKd

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FDA approves Teva Pharmaceuticals and Alvotechs Selarsdi injection as an interchangeable biosimilar to Janssens reference biologic...