Also known as: Health and Human Services, Health and Human Services Department, HHS, U.S. Department of Health and Human Services, US Department of Health and Human Services, U.S. Health and Human Services
HRSA announced a revised 340B Rebate Model Pilot Program effective January 1, 2027, letting manufacturers use rebates instead of upfront discounts. Rebate plans are due August 24, 2026.
FDA issued EUAs for Dectomax and CLiK Extra against New World screwworm. Dectomax is for prevention/treatment in dairy cattle, swine, horses, sheep, deer. CLiK Extra prevents myiasis in livestock, camelids, wildlife.
FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine for adults 50+. It was 27% more effective than standard flu shots in a large trial. The approval came after earlier FDA pushback.
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
Lawmakers opened national security probes into Merck, AbbVie and others over China drug trials. A survey finds China closing in on U.S. biotech leadership, and HHS launched clinical trial reforms to counter the rise.
The European Commission granted marketing authorization to Sandoz for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins developed by Gan & Lee Pharmaceuticals. A recent HHS analysis found most biosimilar markets become economically unviable after five competitors, prompting companies to diversify portfolios. Accord aims to bring 20 biosimilars to market by 2030.
The Agency for Healthcare Research and Quality has cut off continuing funding for at least 73 projects, totaling over $102 million in committed funds. HHS says the move serves the federal government's best interest, but researchers warn that mid-stream grant freezes waste already-spent money and threaten the training of future health-care scientists.
CDC suppressed COVID-19 vaccine data; federal agencies may remove vaccines from the US market. Clinicians cite a JAMA study: 40% efficacy against hospitalization, 79% against severe outcomes.
The FDA will allow food makers to claim "no artificial colors" as long as dyes are not petroleum-based, even if products contain titanium dioxide. Health experts warn the labeling deceives consumers, as naturally derived additives like titanium dioxide pose health risks and remain unregulated.
HHS launches broad initiative to boost US clinical trials amid global competition with China. FDA introduces real-time clinical trial monitoring and expedited programs. NIH Long COVID trials set to begin enrolling participants in summer 2026.
