The FDA has declined to approve a new oncolytic immunotherapy, vusolimogene oderparepvec (RP1), to treat advanced melanoma.

The FDA’s approval of the natural food dye relates to the ongoing removal of petroleum-based dyes from major food brands, including Kraft Heinz, General Mills, and Nestle, just to name a few.

Replimune stock fell after the FDA rejected its RP1 application, citing flaws in the trial design and lack of substantial evidence for approval.

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the ...

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 said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and longtime Stanford University professor, as the director of the Center for ...

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

FDA Greenlights Game-Changing UV Technology That Could Make Raw Milk Safer to Consume Tamarack Biotics’ TruActive process targets pathogens with UV light while keeping the milk’s enzymes and ...

Food and Drug Administration FDA publishes press release written by commissioner to highlight efforts from first 100 days, including efforts to make food healthier ...

The manufacturer announced a recall of 67,214 cases of its Power Stick roll-on deodorant due to violations of Current Good Manufacturing Practices.

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from liver failure after taking it or a similar treatment.