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.
The FDA approved Moderna's mFlusiva, the first mRNA-based flu vaccine, for adults 50 and older. Full approval covers ages 50-64; accelerated approval covers 65+. Moderna expects availability later this year, pending CDC recommendation.
Federal courts are weighing whether the April 2026 marijuana rescheduling order was lawful. MMJ argues the Attorney General skipped required rulemaking; DEA testimony flagged omitted diversion analysis. A stay motion is pending.
FDA final guidance sets standards for psychedelic clinical trials. Federal agencies and states are advancing psilocybin and ibogaine research, and Eli Lilly is acquiring AtaiBeckley for $2.8 billion.
The FDA has finalized the revocation of Orange B and proposed revoking Citrus Red No. 2, while exercising enforcement discretion to permit ‘no artificial colors’ claims on foods that avoid petroleum‑based dyes. The actions are part of a broader initiative to phase out synthetic dyes and fast‑track natural alternatives.
The FDA proposes to remove three GLP-1 drugs from the bulk compounding list as adverse events near 2,000 and Senator Tom Cotton demands a probe into Chinese APIs in compounded meds. Shortages have largely resolved, but safety and innovation concerns persist.
The FDA now allows "no artificial colors" labeling claims for foods without FD&C-certified synthetic colors, part of federal efforts to transition away from petroleum-based dyes. The agency approved beetroot red and expanded spirulina extract uses while initiating a safety review of preservative BHA.
An FDA advisory panel unanimously recommended approval of Moderna's mRNA flu vaccine mFlusiva for adults 50 and older. The vaccine showed a 27% reduction in flu cases versus a standard shot. A final FDA decision is expected by early August.
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.
The FDA pulled back publication of several studies on COVID-19 and shingles vaccines. The blocked studies involved millions of patient records, and two COVID-19 papers were withdrawn in October 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07569029 |
A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies |
RECRUITING | PHASE1 |
| NCT07478471 |
Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax |
NOT_YET_RECRUITING | |
| NCT07446647 |
Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion |
RECRUITING | PHASE1 |
| NCT07390955 |
A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1 |
RECRUITING | PHASE1 |
| NCT07204444 |
The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT) |
COMPLETED | NA |
| NCT07001254 |
UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia |
NOT_YET_RECRUITING | PHASE2 |
| NCT06990724 |
Effectiveness Testing of a Videogame Intervention (No Baby No) to Decrease Contraception Non-use Among Adolescents. |
RECRUITING | NA |
| NCT06919016 |
A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06905275 |
A Clinical Trial to Evaluate the Safety and Immunogenicity of Glycan-trimmed HIV-1 Nanoparticle Vaccine (UVAX-1107), Followed by Homologous or Wild-type HIV-1 Nanoparticle Vaccine (UVAX-1197) Boost, Each Adjuvanted With 3M-052-AF + Alum in Adult Participants Without HIV |
SUSPENDED | PHASE1 |
| NCT06812494 |
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV |
ACTIVE_NOT_RECRUITING | PHASE2 |
