• Posted April 2, 2026

FDA Approves New Weight Loss Pill in Record Time

A new daily pill to help with weight loss has been approved by the U.S. Food and Drug Administration (FDA), and it moved through review faster than most drugs in recent years.

The drug, called Foundayo and developed for Eli Lilly, was approved in just 50 days. That’s 294 days ahead of schedule.

It is the fastest approval of a new type of drug, known as a new molecular entity, since 2002, the FDA said.

Foundayo is approved for adults with obesity or those who are overweight and have at least one related health condition.

It is to be alongside a lower-calorie diet and increased exercise.

The pill is taken once daily and works by targeting GLP-1 receptors, which help control appetite and blood sugar.

The approval was based on two large clinical trials.

Adults who took the drug for 72 weeks, along with a consistent diet and exercise, lost significantly more weight than those who took a placebo.

The drug was reviewed under a newer FDA program designed to speed up treatments for critical health issues.

“This approval demonstrates what the FDA can achieve when we eliminate delays and prioritize fast and thorough work from the agency and industry partners,” said FDA Commissioner Dr. Martin Makary.

“By cutting idle time and maintaining constant communications with the company throughout the review process, we completed this national priority review with outstanding efficiency, while upholding the FDA’s gold-standard science," he said in a news release. "This reflects the level of performance the public should expect from the FDA."

Dr. Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research, said the program helped bring "effective treatments to Americans" much faster.

Like other weight loss drugs, Foundayo can cause side effects.

Common ones include nausea, diarrhea, constipation, vomiting and stomach pain.

The drug also comes with more serious warnings, including risks of:

• Pancreatitis

• Kidney problems

• Low blood sugar

• Gallbladder disease

It also has a boxed warning for thyroid tumors and should not be used by people with certain thyroid cancers, the FDA said.

Foundayo should not be taken with other GLP-1 drugs, and doctors can slowly increase the dose over time, depending on how well the patient tolerates it.

More information

The Cleveland Clinic has more on GLP-1 agonists.

SOURCE: U.S. Food and Drug Administration, news release, April 1, 2026