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In Week 32, the FDA landscape included: Takedaโs approval of ORZEYFUL, a new molecular entity for narcolepsy type 1 De Novo authorization for Auris Healthโs OTTAVA Robotic Surgical System PMA approval for Freenomeโs SimpleScreen CRC 79 medical device clearances 4 significant Warning Letters involving CGMP and quality issues 32 Asia-related regulatory events, including Samsungโs Sleep Apnea software feature and new entrants from China and South Korea Upcoming PDUFA watch items, including Bristol Myers Squibbโs iberdomide on August 17 Iโve summarized these developments in this weekโs FDA Weekly Intelligence report
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