This blog delves into the rise of rare disease drug approvals and the critical importance of regulatory guidance in shaping ...

The Food and Drug Administration on Thursday approved a core component of a brain implant made by Precision Neuroscience, a ...

After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial and ...

The nonprofit Physicians Committee for Responsible Medicine, which promotes the use of human-relevant test methods to replace ...

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

About one week after FDA announced a RIF, the agency began drafting a statement of work seeking contractors to do the same ...

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

The FDA announced a shift away from animal testing for drug approval, citing advanced alternatives like AI and organoids ...

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

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

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.

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