The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
Moderna reported Q4 revenues of $678 million, down 29.8% year-over-year but beating analyst expectations. The FDA reversed course and will review the company's mRNA flu vaccine application.
Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, will depart the agency by the end of April to return to an academic role at the University of California San Francisco.
Health Secretary Robert F. Kennedy Jr. is drawing criticism from anti-vaccine supporters who believe he has not gone far enough in dismantling vaccine programs, following regulatory reversals including the restoration of an mRNA flu shot review.
The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
The FDA reversed its initial refusal and will now review Moderna's mRNA-based flu vaccine application, seeking full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision targeted for August 5, 2026.
The FDA mandated febrile seizure warnings for flu vaccines and rejected Moderna's mRNA flu vaccine application, with a political appointee overruling agency staff despite no safety concerns identified.
The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.
