In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with ...

Modular Medical (MODD) announced that BSI Group will serve as the notified body for the European regulatory clearance process. Unlike the U.S.

Financial writer recommends Voyager Therapeutics, Inc. for high-risk investors due to promising preclinical Alzheimer's ...

The FDA’s nod for suzetrigine bolsters confidence in the pharmaceutical industry’s strategy to target sodium channels.

Government regulators can often play a role in civil litigation. In some cases, they’re involved as parties. More often, however, their role is as ...