There was a lot of excitement when Tepezza became the first drug approved for the treatment of thyroid eye disease in January ...

LONDON — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

Since Dr. Vinay Prasad’s appointment as a key political voice within FDA, the tone of U.S. biotech policy has shifted from ...

Israeli food tech firm Believer Meats has secured US FDA approval for its cultivated meat, and completed the construction of ...

China's Sciwind Biosciences is in talks with a U.S. company interested in licensing its experimental weight-loss drug for ...

Tinnitus affects more than 25 million adults in the U.S., according to the American Tinnitus Association, and roughly 10% of ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

The FDA’s approval of linvoseltamab for adults with heavily pretreated relapsed/refractory multiple myeloma marks a significant advance, with Sundar Jagannath, MBBS, emphasizing its high response ...