FDA-approved drugs are also often patented and subject to various laws regarding exclusivity for a given manufacturer. At the ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like irregular heart rhythm or sleep apnea alerts. They are usually labeled as such.

Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This ...

OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for ...

Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties ...

The FDA approved the sale of Zyn nicotine pouches, which are increasingly popular with teens. But nicotine pouches cause addiction, as smoking and vaping also do.

FDA drug alerts in endocrinology, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label ...

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...

On January 16, 2025, the U.S. Food and Drug Administration (FDA) authorized the sale of Zyn nicotine pouch products, citing potential health benefits for adult smokers. Nicotine, rather than ...

Chemicals such as titanium dioxide and potassium bromate, whose safety has been debated, are allowed in foods in the United ...