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U.S. FDA
Biotech
Nuvalent trots out strong pivotal data in FDA lung cancer push
Nuvalent is eyeing an FDA rolling submission for its ROS1 inhibitor in TKI-pretreated lung cancer after releasing competitive pivotal data.
Angus Liu
Jun 24, 2025 6:30am
China proposal would match US clinical trial review times
Jun 16, 2025 5:30pm
Fierce Pharma
2nd patient dies after Sarepta's DMD gene therapy Elevidys
Jun 16, 2025 10:58am
FDA chides Applied Therapeutics' trial conduct in warning letter
Dec 4, 2024 11:21am
Lykos' MDMA treatment for PTSD has been quashed at the FDA
Aug 10, 2024 9:07am
FDA's Richard Pazdur explains confirmatory trial rejection, more
Apr 8, 2024 6:00am
