The FDA’s regulatory decisions have highlighted internal disagreements, especially regarding COVID-19 vaccines for children and gene therapy approvals. Center for Biologics Evaluation and Research (CBER) head Vinay Prasad has overruled multiple agency reviewers, approving Moderna’s vaccine Spikevax for younger children only if they are at increased risk, citing uncertain benefit for healthy kids amid changing epidemiology. Prasad has also overturned prior decisions related to Sarepta’s Duchenne muscular dystrophy therapy Elevidys, emphasizing caution. Meanwhile, advisory committees have debated Glioblastoma treatment Blenrep’s safety and efficacy. Otsuka’s Rexulti faces scrutiny with the FDA requesting additional data for PTSD indications. These rulings underscore evolving FDA standards and scrutiny of novel therapies.