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