Jason is a general assignment reporter, with particular focus on genetic medicine and rare disease. Confidential tips can be sent on Signal at JasonMast.77. Lizzy leads STAT’s coverage of the FDA. Her ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

Compass Pathways has announced that its investigational psilocybin treatment has successfully met its primary endpoint in a second Phase 3 clinical trial moving it one step closer to FDA submission.

The Securities and Exchange Commission staff has issued fresh guidance on its marketing rule, giving RIAs more clarity around using testimonials from certain disciplined individuals and more ...

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Boise State University’s Online Degree Pathway is an ideal way to explore subjects and work toward earning a bachelor’s degree without committing to a specific program. The program allows you to ...

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NEW YORK, Nov 12 (Reuters) - The U.S. Food and Drug Administration can approve new personalized treatments for rare and deadly genetic diseases based on data from a handful of patients, two of the ...

In a highly anticipated article, FDA officials Vinay Prasad, M.D., and Martin Makary, M.D., outlined a novel regulatory pathway that could trigger a seismic shift in how bespoke gene editing therapies ...

The Food and Drug Administration is unveiling a new blueprint for the regulation of bespoke drug therapies, announcing on Wednesday a way for these treatments to quickly get to market if they meet ...