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
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.
The FDA has shifted from regulatory ambiguity to coordinated enforcement against compounded oral semaglutide, culminating in a 2026 announcement of intent to take action against non-approved GLP-1 drugs. Hims & Hers Health's 2024 oral semaglutide offering marked the beginning of a broader regulatory reckoning that saw manufacturer pressure, formal shortage declarations, and warning letters targeting compounding practices.
HHS Secretary Robert F. Kennedy Jr. announces major reorganization centralizing department operations under CMS leadership, while Duke University telehealth program shows 66% reduction in repeat ER visits for older adults who fall.
The U.S. Department of Health and Human Services formally scrapped its 2025 340B Rebate Model Pilot Program following federal court rulings and issued a new Request for Information on February 13, 2026, seeking stakeholder input on the future of 340B drug pricing.
Sen. Josh Hawley and Rep. Diana Harshbarger introduced legislation to withdraw FDA approval of mifepristone nationwide, making distribution a federal violation and allowing patients to sue manufacturers.
AbbVie reported Q4 earnings that beat consensus estimates with $16.62 billion in revenue, while facing competitive setbacks in psoriatic arthritis and Medicare pricing challenges for Botox.
