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

Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not ...

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

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 ...

Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose ...

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

The small trial will help to establish whether kidneys from genetically modified pigs can be transplanted into people safely and effectively.

But the medication’s modest effectiveness and lengthy development process underscore the challenges ... drug pipeline that involves winning FDA approval for multiple drugs across several forms ...

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