The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

A large number of Australian biotechs are waiting for US FDA product approval – or are on the cusp of ... Read More The post ...

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

Twenty years ago, in 2004, Congress passed the Project BioShield Act, which established the Biomedical Advanced Research and ...

Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in ...