A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

Republicans on the House Appropriations Committee lauded the Make America Healthy Again movement on Wednesday while pushing ...

Lurking beneath the shiny promise of artificial intelligence in health care is a host of potential liability issues, experts ...

Roche warned that President Trump's executive order on drug pricing threatens its planned $50 billion investment in the ...

Good morning! Despite believing that headlines on STAT stories are “terrible,” former FDA head Robert Califf said at ...

Meanwhile, at STAT’s Breakthrough Summit West in San Francisco, former FDA Commissioner Robert Califf criticized RFK Jr.’s ...

CMS and ASTP, the health department’s health IT regulator, released a request for information this week about existing ...

Biotech investors are preparing for what may be the most important clinical trial readout for them this summer.

The health of Native American communities is under threat because of massive cuts to federal health services, tribal leaders ...

Lowering drug prices to European benchmarks would ultimately reduce innovation and cost American consumers just over half a ...

Ex-FDA chief Robert Califf about HHS Secretary Robert F. Kennedy Jr. — “My primary worry is not the FDA, my worry is the ...

The scientists at the University of California, San Francisco and Johns Hopkins University in Baltimore injected an antisense ...