Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...

The FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages.

The FDA now requires updated labeling for all extended-release stimulant medications used to treat attention deficit hyperactivity disorder, warning of increased risk of weight loss and other side ...

Synthetic products posing as kratom mislead and endanger consumers; AKA urges FDA to take decisive action against violative ...

A popular food company is recalling multiple products over misbranding errors on the packaging. Gaiser’s European Style ...

The pivotal trial for Neurogene's Rett syndrome gene therapy makes use of baseline controls and a rigorous endpoint that ...

Abu Dhabi authorities have closed MS Food Trading after serious food safety violations, posing risks to public health. Learn ...

Lawmakers may have had Ivermectin in mind when they passed a law to safeguard doctors who prescribe off-label. But a judge on ...

The USDA just announced a recall of over 143,000 pounds of ready-to-eat bologna due to serious labeling issues. Several ...

Plaintiffs argued the statute would indirectly ban abortion medications by threatening providers with disciplinary action for ...

Explore the latest on VYVGART HYTRULO's FDA safety signal and transition challenges. Learn why argenx's balanced risks keep ...

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...