These amendments represent the first significant changes to “healthy” labeling requirements in 30 years. In its new scheme, ...

Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription Use (ACNU).

“We remain committed to people with HIV who rely on EGRIFTA SV®, as it is the only FDA-approved medicine of its kind, and we will continue to work with the FDA to expedite the release of the new ...

Qiagen has received clearance from U.S. regulators to market its gastrointestinal-illness test.

The government is changing what foods can be branded as “healthy.” It expects basically no one to listen.

On January 6, the US Food and Drug Administration (FDA) published in the Federal Register a notice announcing its ...

The US FDA approved the first generic referencing Victoza, a GLP-1 receptor agonist indicated to improve glycemic control.

In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...

A Guideline Development Group (GDG) meeting at the end of the month aims to establish new guidelines for lenacapavir, a twice ...

Adhesives can do more than just bond two parts together. They can conduct electric current—or insulate current. They can ...

(“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that The Center for Biologics Evaluation and Research (CBER) of the Food ...