The FDA placed a second clinical hold this year on Regenxbio's Hunter syndrome gene therapy after investigators detected masses on the spines of five patients.

The personalized mRNA cancer vaccine from Moderna and Merck has shown positive results, overcoming significant logistical and pandemic-era challenges.

Roche is licensing a Hanmi asset designed to spur weight loss while sparing muscle tissue, with total potential payments of up to $2.3 billion.

The cell therapy manufacturing specialist is restructuring after losing a major customer contract, according to its CEO.

The pop star and her partner are entering the biotech space with a new company, though details of the startup's focus are limited.

The agency is reviewing an updated application for Capricor's cell therapy with a more targeted indication, among other industry news.

FDA's head of digital health policy said the agency expects to issue guidance on regulating generative AI devices.

President Trump's promise to make expensive weight loss drugs widely available to low-income Americans through Medicaid is not materializing.

Legal reasoning used to restrict gender-affirming care for minors could be broadly applied to limit Medicaid coverage of other medications, experts warn.

A study found that restrictions on sugary drink purchases through SNAP led to a modest but meaningful reduction in soda buying.

A preceptor shortage is forcing nurse practitioner students to pay thousands of dollars to secure clinical supervision.