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
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.
The FDA reversed its initial rejection of Moderna's mRNA flu vaccine, agreeing to a normal review after public backlash, while a federal judge invalidated the ACIP advisory committee, leaving the US without functioning vaccine oversight. Moderna's vaccine showed 26.6% greater efficacy than standard flu shots in clinical trials.
HHS and CMS issued a proposed rule to codify the Medicare Drug Price Negotiation Program, largely formalizing existing guidance. The rule includes new provisions, such as clarifications for new drug formulations. The proposal is now open for public comment.
Long COVID patients continue to suffer as federal research funding and support programs have been dramatically scaled back, with the Office of Long COVID Research and Practice closed and NIH grants disrupted. The chronic condition affects as many as a third of COVID-19 survivors with over 200 possible symptoms, yet experts say the disease remains difficult to research amid politicization. Medical professionals warn that reduced resources undermine diagnosis, treatment, and the professional pipeline for new research.
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
The FDA reversed its refusal to review Moderna’s mRNA flu vaccine application and accepted a revised filing with split age cohorts and a post-market study for adults over 65. The reversal came amid broader vaccine regulatory uncertainty and industry concern about unpredictable review timelines.
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
The FDA reversed course and said it would review Moderna’s application for a new mRNA-based flu vaccine. The move followed growing concern about federal vaccine policy and came after HHS canceled nearly $500 million in mRNA vaccine contracts.
President Donald Trump’s April 2, 2026 proclamation sets a 100% Section 232 tariff on certain patented pharmaceuticals and APIs from July 31, 2026. Generics, biosimilars and several specialty categories are exempt, while some companies can qualify for reduced or zero tariffs through onshoring or MFN pricing agreements.
