U.S. Food and Drug Administration

Company

Last mentioned: Mar 25, 2026

Timeline

  1. Target Commercialization

    Anticipated EU launch for iopofosine I 131 treatment of WM.

  2. Trial Expansion

    Continued enrollment across global multicenter sites for the 24-week study.

  3. EMA Submission

    Target window for filing the CMA for iopofosine I 131 in the European Union.

  4. CLR 125 Data Readout

    Expected early data from the Phase 1b study in Triple Negative Breast Cancer.

  5. Phase III Initiation

    First patient dosed at Peking Union Medical College Hospital in China.

  6. Annual Results Announcement

    CEO James Caruso provides corporate updates and confirms regulatory timelines.

  7. Regulatory Designations

    HMI-115 receives FDA Fast Track and NMPA Breakthrough Therapy designations.

  8. Phase II Completion

    Global multicenter Phase II trial results published in The Lancet showing efficacy and safety.

  9. Fiscal Year End

    Cellectar concludes a year focused on pipeline execution and supply chain strengthening.

Stories mentioning U.S. Food and Drug Administration 3

pharma Bearish

Texas Governor Orders Probe into Chinese Medical Device Supply Chain Risks

Texas Governor Greg Abbott has launched a formal investigation into the safety and security of medical devices manufactured in China and used within the state's healthcare system. The move signals a growing trend of state-level scrutiny over international medical supply chains and potential vulnerabilities in critical healthcare infrastructure.

2 sources
Clinical Trials Bullish

Cellectar Biosciences Targets 2027 EU Launch for Iopofosine I 131

Cellectar Biosciences has confirmed its trajectory for a Q3 2026 regulatory submission to the EMA for its lead radiotherapeutic, iopofosine I 131. The company is simultaneously advancing its Phase 1b study of CLR 125 in triple-negative breast cancer, marking a significant expansion of its phospholipid drug conjugate platform.

2 sources

About U.S. Food and Drug Administration coverage

This page surfaces every story mentioning U.S. Food and Drug Administration across our biotech coverage. We track each entity's appearance over time so readers can trace how the narrative evolves — which developments are isolated incidents, which build into longer arcs, and which reframe how operators in the space think about the entity. Story selection uses the same multi-source verification gate applied across the rest of our coverage.

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