Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

"It would not be surprising if we saw longer review times, at least in the near term," Shuren said about the FDA layoffs.

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

FDA CDRH leaders and the entire FDA Office of Media Affairs were reportedly eliminated in the Trump Administration's mass ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...

As a further update to our alert from March 27, the Trump Administration began mass layoffs at US health agencies on April 1.

The FDA says the device, designed to repair broken blood vessels to stem bleeding, showed a “clinically meaningful benefit.” ...

The Supreme Court backed the FDA's refusal to authorize the sale of kid-friendly flavored vapes, including the flavors ...

A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...

WASHINGTON (AP) — The Food and Drug Administration’s chief tobacco regulator has been removed from his post as part of ...