Patient advocacy organizations across the United States are intensifying their efforts to expand access to experimental therapies, arguing that current regulatory frameworks create unnecessary ...

The FDA will now require drug manufacturers to add clear information about the risk of addiction, misuse, and overdose on opioid prescription labels.

The Food and Drug Administration (FDA) has approved San-Francisco-based Wildtype to become the nation’s first company to sell ...

Indian-origin scientist Vinay Prasad resigned as the FDA's vaccine and gene therapy chief in just three months after backlash ...

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

Eli Lilly said on Thursday that its newer diabetes drug Mounjaro outperformed Trulicity, its previously top-selling ...

While several states have enacted the KCPA, products that exceed safe 7-OH thresholds — or contain synthetically derived 7-OH ...

Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...

As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more ...

A new opioid threat you probably haven't heard about is targeting kids. Products containing 7-OH are currently being sold ...

Gas station heroin” took another hit on Wednesday as HHS Secretary Robert F. Kennedy Jr’s FDA recommended a scheduling action ...