The clinical hold is due to questions about BX004’s nebulizer device, temporarily pausing US enrollment in the cystic ...

The company plans to continue with a lower dose and a change in the pre-treatment regimen after a trial participant died ...

Gene Therapy Trial Can Restart After Patient Death, FDA Says. The Sector Remains Depressed. The biotech Rocket ...

The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...

Dining under palm trees on a patio at Mar-a-Lago in December, President-elect Donald Trump reassured chief executives at ...

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

AAP published the new advice on Tuesday, saying it strongly recommends Covid shots for children ages 6 months to 2 years.

He’s using Biden-era mistakes to tarnish a promising technology.

A staffer for HHS Secretary Robert F Kennedy Jr - who drew the ire of President Donald Trump's MAGA base and was fired - ...

Delays from the Food and Drug Administration continue to pile up, with Maryland-based Regenxbio the latest to report the review of one of its assets ...

The American Academy of Pediatrics is splitting from the federal government in its recommendations on which children should ...

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...