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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...

The US Food and Drug Administration (FDA) has created a new pathway to bring personalised therapies to market that can bypass certain requirements, using the success of Baby KJ’s treatment as a ...

Urnov is a professor of molecular therapeutics at the University of California, Berkeley, and a director at its Innovative Genomics Institute. In May, news broke of a biomedical first: the on-demand ...

Schools across the country are offering courses and retreats for people 50+ who want to reinvent themselves and embrace ...

Public engagement is often found at the heart of universities’ mission statements and is key to their institutional identities, but it is rarely central in their promotion and tenure processes. Indeed ...

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 FDA has proposed new guidelines to facilitate the approval of customized treatments for rare diseases, aiming to address ...

“Companies should really sit down and say, could I meet these points?” Hogan Lovells partner Lynn Mehler said. “How do I follow the larger concept at play here, which is FDA willingness to be ...