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Clinical Trials Advisory Committee

Holland & Knight LLP

FDA Rejects Application for Psychedelic Drug

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more

Sands Anderson PC

What Is Intussusception?

Sands Anderson PC on

On average your body has twenty-five feet of organic tubing, the intestines. Like an assembly line in reverse, the intestines break down morsels. As food travels through, the small intestine extracts nutrients and the large...more

Morgan Lewis

FDA Uses Summer to Issue Numerous Device Guidance Documents

Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

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