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FDA Fast Tracks ITM-94 for renal cell carcinoma imaging
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November 18, 2025
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When Jud Kimmel was diagnosed with neuroendocrine cancer, the emotional impact of the diagnosis hit him hard. At the SNMMI annual Theranostics Conference, he spoke about the psychological and emotional toll that a cancer diagnosis takes - especially on men. Jud also discussed his work in the men's health space and offered advice for providers on helping patients through a hard diagnosis.
 
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FDA Fast Tracks ITM-94 for renal cell carcinoma imaging
The FDA granted Fast-Track status to ITM-94, a gallium-68 radiolabeled PET imaging agent for diagnosing clear cell renal cell carcinoma. A Phase 1/2 trial found ITM-94 had a high tumor-to-background ratio and favorable tolerability, and the next phase of the study will assess the agent's effectiveness in classifying indeterminate renal masses.
Full Story: Diagnostic Imaging (11/17), Urology Times (11/17)
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Clinical News & Research
 
Bone-protecting agents may help improve mCRPC survival with enzalutamide plus radium-223
A study presented at the annual meeting of the Western Section of the American Urological Association suggested that bone-protecting agents may help improve outcomes for certain patients with metastatic castration-resistant prostate cancer. Data showed that using bone-protecting agents alongside enzalutamide, including with radium-223, was associated with increased progression-free survival. The use of radium-223 with enzalutamide also was associated with improved survival.
Full Story: UroToday (11/17)
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Cyber threats evolve as fast as technology itself. Join us December 2 at 2PM EST for an in-depth look at the innovations shaping cybersecurity in 2026. Learn from experts how to strengthen your systems, anticipate new risks, and lead with confidence in a changing digital world. Register now.
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Industry Report
 
Supply chain issues affect radiopharmaceutical development
Increased investment in radiopharmaceutical development by major pharmaceutical companies is straining the supply chain, as demand for isotopes such as lutetium-177 can outpace supply and has affected enrollment in one clinical trial. "The lack of access to these drugs, for a lot of folks, was not necessarily due to a limitation of science, but due to a limitation of the logistics and manufacturing and engineering needed to get these drugs out to the world at a cost of scale that matters," said Justin Butler, a partner at Eclipse Ventures.
Full Story: BioSpace (11/18)
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CVAUSA to integrate Flyrcado at 25 sites
GE HealthCare said Cardiovascular Associates of America will use its PET tracer Flyrcado or flurpiridaz F 18 at 25 of its sites to expand PET myocardial perfusion imaging. The decision follows a successful pilot program at Cardiovascular Medicine in Davenport, Iowa.
Full Story: Diagnostic & Interventional Cardiology magazine (11/2025)
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News from the Field
 
More Americans turn to AI for medical advice
 
More Americans turn to AI for medical advice
(Malte Mueller/Getty Images)
Many Americans are turning to AI for medical questions, driven by a frustration with the traditional medical system and AI's 24/7 availability and ease of use. In 2024, 1 in 6 US adults used chatbots to find health information at least once a month, according to a survey from KFF. The New York Times documented dozens of interviews in which people described their experiences using chatbots for medical information or advice.
Full Story: The New York Times (11/16)
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International Developments
 
UK to use lead-212 from recycled nuclear fuel to develop cancer therapies
The UK will use lead-212 from recycled nuclear fuel to develop targeted alpha therapies for precision medicine. The UK National Nuclear Laboratory leads the project and funding will come from the Sustainable Medicines Manufacturing Innovation Program.
Full Story: Worksop Guardian (U.K.) (11/18)
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Kazakh center begins production of 13 radiopharmaceuticals
The National Scientific Oncology Center in Astana, Kazakhstan, has started producing 13 radiopharmaceuticals, enabling a full cycle of PET diagnostics and therapy within a single complex. The new production capabilities will make the center self-sufficient and help to meet the needs of other regions in Kazakhstan.
Full Story: Kazinform International News Agency (Kazakhstan) (11/17)
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Health Policy
 
Oz says all options on table for ACA subsidies
CMS Administrator Mehmet Oz said the Trump administration is open to all options as Affordable Care Act subsidies are set to expire at year's end. "There are discussions around extending subsidies if we deal with the fraud, waste and abuse that right now is paralyzing the system. There are ways of using our money wisely by putting it in the pockets of Americans," Oz said. President Donald Trump has proposed direct payments to Americans instead of insurers, while House Democrats are pushing for a three-year extension of the subsidies.
Full Story: The Hill (11/16)
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