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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…

To kick off 2025, we’re looking back at the radiopharma advancements and challenges that shaped 2024 and laid the groundwork for even greater progress in the year ahead. Here’s a…

At Nucleus RadioPharma, there’s nothing we enjoy more than educating our community on the latest advancements in radiopharmaceuticals, which is why we recently hosted two live events with top experts…

Radiopharmaceuticals present unique barriers to entry, largely due to the interplay between radioactive materials, short shelf life, stringent regulations, and intricate manufacturing processes. Operationally, radiopharmaceuticals require a level of precision…

Unlike more traditional pharmaceuticals with well-established manufacturing supply chains, radiotherapies have unique challenges and complexities to consider before choosing a contract development and manufacturing organization (CDMO) partner. The short shelf-life…