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FDA Extends Postponement of Inspections Until 2/4

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FDA extends until 2/4 a temporary postponement of certain inspection activities due to the spread of the omicron variant.

FDA Met or Exceeded Many FY 2020 User Fee Goals

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The latest FDA user fee performance report shows the agency met or exceeded many of its FY 2020 PDUFA and BsUFA goals in several d...

FDA Neuroscience Deputy Bastings Retires, Joins Ionis

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Under the cloud of an HHS inspector general probe of alleged FDA coziness in the controversial approval of Biogens Alzheimers ther...

FDA Tells Revance to Qualify New Working Cell Bank

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FDA tells Revance Therapeutics that to address a recent BLA complete response letter on DaxibotulinumtoxinA for Injection will req...

FDA Agrees to New Nomacopan Trial Process

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FDA approves a higher-yield manufacturing process for Akari Therapeutics nomacopan for use in two Phase 3 trials.

FDA Schedules Remote Data Acquisition Webinar

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FDA schedules a 2/10 Webinar on its draft guidance on digital health technologies for remote data acquisition.

FDA Yumanity Parkinsons Trial Hold

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FDA puts a partial clinical hold on multi-dose trials of Yumanity Therapeutics investigational Parkinsons disease drug.

Regeneron sBLA for Libtayo in Lung Cancer

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FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination wi...

Policy Changes and More Enforcement Coming?

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Three Skadden Arps attorneys explore the reasons why life sciences companies may see increased enforcement activity from FDA and t...

$250 Million in Counterfeit HIV Drugs Sold: Gilead

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Gilead says it believes it has stopped the distribution of counterfeit HIV drugs from reaching patients.