FDA commissioner Robert Califf’s second term is anticipated to end in 2025, and all eyes are now on who will be the next to ...

Trump no longer has to pretend he wants to be the protector of women. “FDA's Center for Food Safety and Applied Nutrition ...

With the FDA's acceptance of Urogen's NDA and issuance of an 06/13/2025 PDUFA the clock is now ticking for FDA approval of ...

Nearly 300,000 bottles of the drug, named Cinacalcet, were recalled and given a Class II recall risk level by the FDA.

Fourth Frontier has achieved a crucial milestone with the FDA's clearance of the Frontier X Plus, a single-lead ECG monitor. Positioned to enhance heart health monitoring, this wearable device ...

“The FDA obviously affects what gets approved, but once things are approved, it’s a states’ rights issue,” Dr. Mitchell Katz, ...

The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...

Biotech companies have brought many important treatments to market, from ones that address rare diseases to ones that handle ...

In early June, villagers seized a team of miners and their equipment for operating in the Salayea Community Forest without ...

Recent quality and operational issues at Smiths, which originated before it was purchased, greatly reduced ICU’s gross margin after the acquisition. These issues have required additional spending to ...