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ODAC Looking at Long Delays in 2 Acrotech Trials

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FDA asks the Oncologic Drugs Advisory Committee whether Acrotech Biopharmas plan to complete a confirmatory trial for two cancer d...

Cardinal Health Recalls Infusion Pump Syringes

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Cardinal Health recalls its latest version (6/2023) of its Monoject syringes branded as Cardinal Health Monoject syringes because ...

Comments on Cell & Gene Comparability Guide

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Four stakeholders comment on an FDA draft guidance on comparability of human cell and gene therapy products and suggest improvemen...

Imfinzi Phase 3 Trial Fails

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AstraZeneca says its Imfinzi failed to achieve statistical significance in the PACIFIC-2 trial in some non-small cell lung cancer ...

FDA Lawyer Nguyen Moves to Cooley

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Law firm Cooley adds 14-year FDA lawyer Son Nguyen to the firms Washington, DC office.

Congress Should Do More on Drug Shortages: Analysis

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Manhattan Institute senior fellow and former FDAer Randall Lutter says there are many things Congress should be doing to alleviate...

Improve Post-Market Evidence Generation: Report

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The Reagan-Udall Foundation recommends steps to be taken by FDA and other stakeholders to improve evidence generation in postmarke...

Covidien Recalls Stolen Video Laryngoscopes

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Covidien recalls its McGrath MAC Video Laryngoscope in a move to remove stolen defective models that have been offered for sale il...

Republicans Threaten Subpoena on FDA Research

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House Energy and Commerce Committee Republicans threaten FDA with a subpoena if it continues to delay submitting documents on what...

BridgeBio Filing NDA for Acoramidis

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BridgeBio Pharma says it will file by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acor...