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FDA Requires Label Update for Agios Pharmaceuticals' Pyrukynd

The US Food and Drug Administration has mandated Agios Pharmaceuticals to update the label of its hemolytic anemia drug, Pyrukynd, to include the risk of liver injury. This move comes amidst other significant developments in the pharmaceutical sector, including positive Phase II results from Oculis Holdings and a licensing deal between Climb Bio and Mabworks Biotech.

Among significant news last week, the US Food and Drug Administration (FDA) required Agios Pharmaceuticals to amend the label for its hemolytic anemia drug Pyrukynd to reflect the risk of liver injury. Swiss ophthalmic drugs developer Oculis Holdings released positive Phase II results for its OCS-05. US drug developer Climb Bio entered into a licensing deal with China-based Mabworks Biotech on the latter’s monoclonal antibody CLYM116/MIL116. Also of note, US CRISPR gene editing company Intellia Therapeutics announced strategic plans which included cuts in programs and workforce.
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Reference News

[1]
action, reaction and insight – week to January 10
thepharmaletter.com · Jan 12, 2025

FDA required Agios Pharmaceuticals to update Pyrukynd's label for liver injury risk. Oculis Holdings reported positive P...

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