INSYS Therapeutics, Inc.
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Latest From INSYS Therapeutics, Inc.
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Breakthrough Designation Binge In February By US FDA Didn’t Extend To Approvals
Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.
The Impossible Task Of Regulating AI In Life Sciences
With specific and enforceable regulations for artificial intelligence in the life sciences unlikely anytime soon, companies need to follow their own ethical principles.
Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance
Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.
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- NeoPharm, Inc.
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