FDA Action Update, May 2026: Approvals, Priority Review, and Extension of Review

• The CDC paused diagnostic testing for rabies, mpox, and over 24 other diseases in March 2026 following significant staffing reductions. • As of July 1, the agency has not provided public clarity regarding the restoration status of these critical diagnostic services.

• The CDC is providing updates on Ebola outbreaks currently affecting the Democratic Republic of the Congo and Uganda. • The agency is also preparing its "activation" strategy for the upcoming 2026 World Cup to manage public health risks.

• The CDC's malaria testing branch faced severe budget or operational cuts in spring 2026, surpassing the reductions seen in the rabies lab. • These cuts threaten the ability to identify specific malaria species, which is critical for determining the correct medical treatment for patients.

• CDC surveillance data indicates that parainfluenza virus and human metapneumovirus levels are currently elevated across the United States this summer. • Because no vaccines exist for these two respiratory viruses, parents are advised to monitor symptoms and understand the risks associated with these infections.

• The US Food and Drug Administration (FDA) approved 22 novel drugs during the first half of 2026, expanding treatment options across various medical specialties. • Key approvals include copper histidinate (formerly CUTX-101) for Menkes disease, supported by two open-label studies involving 129 patients treated with subcutaneous administration for up to 3 years.

• The Trump administration is reversing a decade-long policy of providing federal funding for clean needle programs, leaving syringe services in a state of uncertainty. • Experts, including former White House official Regina LaBelle, warn that these cuts may force programs to reduce hours or eliminate services, potentially triggering new outbreaks of blood-borne diseases.

• The World Health Organization (WHO) has launched a new "blueprint" designed to assist nations in combating the escalating threat of fungal infections and antifungal resistance. • A concurrent CDC surveillance study reveals a sharp increase in *Candida auris* cases within US hospitals, rising from 2,882 in 2022 to 6,197 in 2024.

• Two peer-reviewed reports published this week analyzed measles outbreaks in Texas and South Carolina to determine the primary barriers to disease control. • The findings reveal that a lack of community trust, rather than simply low vaccination rates, serves as the central obstacle to stopping the outbreaks.

• A recent New England Journal of Medicine (NEJM) pragmatic trial tested a 6-month rifampicin-resistant tuberculosis (RR-TB) regimen, establishing a new benchmark for adaptive evidence generation. • The trial embedded randomization directly into existing treatment infrastructure to bypass the lengthy 18-month site qualification and rigid eligibility criteria typical of conventional Phase 3 development.

• Researchers report that a modified form of vitamin B12 may provide a promising new strategy for treating deadly brain cancer. • A two-year clinical trial published in eBioMedicine involving 365 adults aged 55 to 80 found that high-dose omega-3 fish oil supplements did not improve memory or cognitive abilities.

• Federal authorities executed the largest healthcare fraud takedown of 2026, charging 455 defendants, including 90 doctors. • The operation targeted $6.5 billion in false claims and uncovered cases involving patient deaths.

• The FDA approved the updated COVID-19 vaccine strain in May, but official guidance on who should receive it remains unavailable. • A critical lack of a quorum since March has stalled the committee responsible for determining eligibility and insurance coverage for the fall rollout.