federal drug administration

Aduhelm approval sparks HHS watchdog review of FDA’s accelerated approval pathway

The Department of Health and Human Services (HHS) Office of the Inspector General will review the FDA’s accelerated approval pathway, the office announced Wednesday. This sweeping review comes just

Risks and rewards of digital therapeutics in treating mental disorders

More Americans than ever before are suffering from mental and emotional distress. Because the resources for those living with mental health issues are constrained, startups could have a big impact.

Medical device maker Medtronic finally fixes its hackable pacemaker

Medtronic, a maker of medical devices and implants, has pulled the plug on its internet-based software update system, which security researchers had found had a dangerous security vulnerability The co

Sorry kids, the FDA just made it a lot harder for you to vape

New rules from the FDA that go into effect today are set to make it a lot tougher for youngsters under 18 to get their hands on e-cigarettes and related paraphernalia. Among the regulations are rules