In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment (AI-COA), as a qualified drug development tool.

After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.

Enveric Biosciences Inc. has named EB-003 as its lead drug candidate from the company’s next-generation EVM301 series. EB-003 was selected based on data analyses suggesting the molecule’s potential to be a first-in-class approach to addressing difficult-to-treat mental health disorders by promoting neuroplasticity without inducing hallucinations.

Researchers from Anhui University presented the discovery and preclinical evaluation of novel negative allosteric modulators (NAMs) of the metabotropic glutamate mGlu5 receptor.

Enveric Biosciences Inc. has identified three novel compounds from its EVM301 series with the potential to offer a first-in-class approach to address difficult-to-treat mental health disorders by promoting neuroplasticity without inducing hallucinations.

Mira Pharmaceuticals Inc. has reported findings on the cognitive enhancing effects of MIRA-1a, an unscheduled novel synthetic tetrahydrocannabinol (THC) analogue, in normal mice.

Electromedical Products International Inc. (EPI) Alpha-Stim AID technology is finally being made available by the NHS in the U.K. to treat patients with anxiety some two years after the National Institute for Health and Care Excellence (NICE) said there was not enough good-quality evidence to support the case for routine adoption.

Psilera Inc. has selected a novel, non-hallucinogenic psilocybin derivative, PSIL-006...