Federal regulators have warned the maker of Ozempic and Wegovy that it failed to report possible drug side effects to the ...

The DCB currently remains an investigational device and is not available for sale in the US. "Airiver Medical receives FDA ...

The FDA has faced an extraordinary convergence of political, scientific, legal, and operational pressures over the last year.

The FDA is targeting telehealth marketing of GLP-1 drugs. But those companies may not be the only ones under the microscope.

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...

The FDA narrowed leucovorin's use to a rare disorder, a major shift after Trump and RFK Jr. promoted it for autism.

It’s no question that technology is expanding at a rapid pace, impacting devices in all fields, from manufacturing to medicine. When new developments come to fruition in the medical space, companies ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...