The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug in combination with Viatris' Zoloft for the treatment of adults with PTSD.

The FDA clears GL-IL2-138, a groundbreaking oral drug modulating natural IL-2, set to revolutionize treatment in oncology. The FDA has cleared an investigational new drug (IND) application for GL-IL2-138. GL-IL2-138 is a small-molecule modulator of natural interleukin-2 (IL-2).

By Stephanie Brown HealthDay ReporterTUESDAY, July 15, 2025 (HealthDay News) -- The U.S Food and Drug Administration has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.

A recall of potato chips due to the possible presence of an undeclared allergen has been issued the second-highest risk warning by the U.S. Food and Drug Administration ( FDA ). Saratoga Potato Chips LLC, based in Indiana, issued a voluntary recall for more than 2,000 bags of chips due to the undeclared presence of milk on July 7.

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in young children.

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging from mold to skirted testing procedures.  | The FDA listed observations at plants run by Sun Pharma,

After state lawmakers outlawed the fluoridation of communities' waters, a Utah dentist is testifying to the FDA to encourage them not to follow through with plans to ban kids' fluoride supplements.

MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet issue for Commissioner Marty Makary that’s separately garnered attention in the states and on social media.

The FDA told Whoop that its Blood Pressure Insights feature (available only on the Whoop MG with the top-tier Life membership) runs afoul of the law. The feature is still available for now. Read on for more on what the FDA said,

The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.

For decades, proponents of psychedelic drugs have come to Washington with a provocative message: Illegal, mind-altering substances like LSD and ecstasy should be approved for Americans grappling with depression,