• Posted April 15, 2026

New Weight Loss Pill Gets Approval But FDA Seeks More Safety Data

The U.S. Food and Drug Administration (FDA) has told Eli Lilly to study possible heart, liver and other risks tied to its new obesity drug Foundayo, according to an approval letter released Tuesday.

Foundayo was approved earlier this month through an FDA pilot program designed to speed up drug reviews. 

It is the second oral GLP-1 drugs available, providing people with an alternative to injectable treatments.

But the FDA said current data isn’t enough to fully understand some of the potential risks. 

The agency has asked the company to study serious conditions such as heart attack, stroke and drug-related liver injury. 

It also wants more information on delayed stomach emptying, a condition in which food stays in the stomach too long, NBC News reported.

What's more, the FDA is requiring long-term research on a possible link to thyroid cancer. 

Injectable versions of these drugs already carry a boxed warning for this risk, and the agency wants Lilly to track patients for at least 15 years, NBC News said.

Foundayo uses a newer active ingredient, called orforglipron, which lacks the same level of long-term safety data as older drugs.

The FDA did not request similar additional studies when the oral version of Wegovy was approved. It contains semaglutide, which has been studied since 2017.

“With orforglipron, it’s a newer, non-peptide version of a GLP-1, so we don’t yet have the same depth of safety data as the injectables,” Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina, told NBC News.

“It doesn’t mean a safety problem has been found," he said. "It means they want more definitive long-term data.”

The FDA is also asking for additional studies, including a registry to track children with obesity who use weight loss drugs and another to monitor outcomes in pregnant patients.

A spokesperson for Eli Lilly said these post-approval requirements are routine.

“Patient safety is Lilly’s top priority and we actively monitor, evaluate and report safety information for all our medicines,” the spokesperson said.

More information

The U.S. Food and Drug Administration has more on its fast track program.

SOURCE: NBC News, April 14, 2026