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

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

The drug, Journavx, from Vertex Pharmaceuticals, reduced pain after surgery in clinical trials. Experts hope it can lead to fewer opioid prescriptions.

The FDA approved a pain drug designed to eliminate the risks associated with opioids -- the first new pharmaceutical approach ...

Vertex has gained the FDA's approval for its non-addictive pain med Journavx, which becomes the first significant innovation in pain relief in more than two decades.

Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...

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

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

The decision builds on previous FDA approval for the drug’s treatment when combined ... Spravato’s approval through its Priority Review process after receiving results from a randomized ...

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

Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...

The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class ... clinicians with their decision-making process, and it helps them focus those ...