Many of the directions included in the order will be familiar to those who watched drug pricing policy closely during the ...

The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab ...

The executive order targets lower drug prices through Medicare reforms, anticompetitive crackdowns, and transparency mandates.

In his first major action on health care costs this term, President Donald Trump issued a multi-part executive order on ...

J&J’s comments and guidance update come as the company kicks off 2025’s first-quarter earnings round for large drugmakers.

Rare diseases, often referred to as orphan diseases, affect small patient populations, yet collectively they impact more than ...

After years of back-and-forth with the FDA over Hetlioz's potential use as a jet lag disorder treatment, Vanda ...

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...

In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S.

The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal ...

The FDA granted Breakthrough Therapy designation to IDE196 for the neoadjuvant treatment of primary uveal melanoma when enucleation has been recommended.

In a unanimous decision on Wednesday, the Supreme Court rejected an appeals court's conclusion that the Food and Drug ...