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FDA Roundup: August 20, 2024

Follow FDA on Facebook 20 August 2024 Super Admin

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

  • On Monday, the FDA approved Lazcluze (lazertinib) in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Full prescribing information for Lazcluze and Rybrevant will be posted on Drugs@FDA.
  • Save the Date: On Dec. 17 and 18, 2024, there will be a joint NIH-FDA Nutrition Regulatory Science Workshop. The goal of this joint NIH-FDA workshop is to highlight how nutrition science can generate evidence and data to inform food-related policy and regulatory decision making and to foster additional collaboration between NIH and FDA in supporting research that addresses priority nutrition research gaps. Examples of topics that will be discussed at the workshop include ultra-processed foods, impact analysis and implementation science related to regulatory actions, and emerging technological innovations related to nutrition regulatory science.