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The FDA’s recent draft guidance for radiopharmaceuticals marks a pivotal moment for the field. For the first time, the agency provided clearer expectations for how these therapies should be developed,…

In radiopharmaceuticals, preclinical success isn’t just about demonstrating activity but building something that can survive contact with reality. That means processes that can scale, compliance strategies that hold up under…

With new isotopes entering clinical trials and therapies showing promise across oncology, the pipeline for radiopharmaceuticals is expanding. Yet even as science accelerates, supply chain vulnerabilities remain one of the…

The road from discovery to commercialization is complex for any therapeutic—but in radiopharmaceuticals, that journey brings an entirely different level of scientific and regulatory intricacy.  Developers working in radiopharmaceuticals often…

Radiopharmaceutical therapies require a completely different approach to drug delivery—slow, highly controlled infusions, radiation shielding, and strict adherence to regulatory standards. Yet most treatment centers are currently adapting tools that…

Each phase of radiotherapy development brings its own technical, regulatory, and operational challenges. The requirements shift rapidly as you move from early-stage formulation to commercial manufacturing, and so must your…

As demand for life-extending radiotherapies grows, organizations must look beyond clinical development and ask a crucial question: Can we make this at scale without compromising quality or speed? Unlike traditional…

Bringing a radiopharmaceutical therapy to market requires more than just scientific, clinical, and manufacturing breakthroughs. Once your therapy is ready for patients, successful delivery and administration depends on a complex…

Compliance with 21 CFR 211 which applies to all pharmaceuticals, and 21 CFR 212, which specifically governs PET drug manufacturing, sets the foundation for quality and production standards in radiopharmaceutical…

The Centers for Medicare & Medicaid Services (CMS) introduced its final rule for CY2025, and its updates carry far-reaching implications for patients, healthcare providers, and, of course, radiopharmaceutical developers and…