Multiple Firsts As Pexidartinib Approved In US - With Warning
Further progress for Daiichi Sankyo's strategic push into oncology as US issues first approval globally for first-in-class rare disease drug Turalio - but with liver toxicity safeguards.
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The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA still deliberating on how best to measure success of the liver safety program for Daiichi's TGCT treatment, but REMS will probably assess both process and outcomes.
Results from a large Swedish study provide further evidence that mixing different COVID-19 vaccines boosts effectiveness. Meanwhile, Japan plans new funding to support the home-grown development of coronavirus and other vaccines.