A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat menopause. The 12-person panel encouraged the use of the treatment late last week and called for the removal of the Food and Drug Administration’s “black box” warning label on hormone treatments.

Replimune (NASDAQ:REPL) announced on Tuesday that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding its marketing application for its lead asset, RP1, declining to approve it as part of a combination regimen for melanoma,

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s top drug regulator, the agency confirmed Monday.

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner Marty Makary called Tidmarsh an "accomplished physician-scientist and leader."

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s Center for Drug Evaluation and Research, which regulates the safety and effectiveness of all U.S. drugs.

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the majority of new drug applications.

Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing seven FDA-approved drugs.

“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development — from bench to bedside,” FDA Commissioner Marty Makary said in a statement. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.”

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational gene therapy trials for limb girdle muscular dystrophy following three patient deaths potentially linked to the company's treatments.

The U.S. Food and Drug Administration has approved GSK's prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster).

The FDA plans to revoke 52 outdated nutrition and labeling regulations to streamline food industry standards, citing them as obsolete and no longer necessary for modern practices.