From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.

In 2024, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping ...

The US FDA has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research.

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...

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

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 ...

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 ...