FDA Approves New Weight Loss Pill, Foundayo, in Record Time

Follow Drugslib on

By HealthDay Staff HealthDay Reporter

Amazon Big Spring Sale - Up to 40% off

Medically reviewed by Carmen Pope, BPharm. Last updated on April 2, 2026.

via HealthDay

THURSDAY, April 2, 2026 — 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

    Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2026-04-03 08:58

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords