Despite the Trump administration's shake-up of the agency, the US FDA is the first port of call for most ASX biotechs.

Joseph Borzelleca published a study on the food coloring Red No. 3. The FDA cited his work when banning the additive in January. But the researcher says the dye is safe ...

The MagDI System is a self-aligning, incisionless, sutureless and staple-free technology for surgical linkage.

Pramand LLC announced today the US commercial launch of the SpineSeal Spine Sealant System following recent premarket ...

Miach Orthopaedics announced today that the FDA cleared an expanded indication for the company's Bear implant for ACL tears.

but drug companies and some obesity specialists have expressed concerns that some compounded products aren’t FDA-approved. Sooners Host Pro Day Do you need a measles booster amid rising cases? Mexico ...

The FDA is reviewing the supplemental NDA for cabozantinib ... The Company is seeking approval for acute treatment of migraine with or without aura.

With RFK Jr. at the HHS helm, the $70-billion industry may push bolder health claims and government payment policies.

The analyst gave Washington an A grade, which represents a major seal of approval that this upstart contender stands to benefit from greatly next season and potentially beyond. The Commanders had ...

The FDA is reviewing the application for bentracimab for use as a ticagrelor reversal agent in patients with uncontrolled bleeding or in those who require urgent surgery or invasive procedure.

It noted at the time more countries would get access as regulators approved the feature, and the FDA was apparently the first to come through outside of Europe, boosting support to 15 countries.