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- FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancerThe U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
- FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populationsThe FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…fda press · 25d agoRegulatoryPositive