The Utah Dental Association (UDA) has issued an urgent guidance days after the U.S. Food and Drug Administration (FDA) moved ...

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...

The Danish drugmaker has gone from steady to chaotic. Its fight with Pfizer to acquire Metsera is getting more heated.

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...

Direct-to-consumer drug advertising is already the most heavily regulated form of commercial speech in America. It does not need more.

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...

The agency announced new draft guidance to simplify biosimilarity studies and reduce clinical testing that it has deemed ...

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...

The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting ...

The FDA announced it will relax certain rules for approving low-cost versions of some high-priced medications.

Texas Attorney General Ken Paxton has asked a federal judge to force the makers of Tylenol to stop any advertising that the ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs.  The ...