Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

This milestone marks a breakthrough after unsuccessful attempts to develop painkillers without the addictive potential of ...

Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...

Lately, one of America's leading pharmaceutical companies can't catch a break from Wall Street. Shares of Vertex ...

A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.