Xtalks

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Ibtrozi Wins FDA Approval for ROS1+ NSCLC, Set to Challenge Reigning TKIs Xalkori, Augtyro and Rozlytrek

1 week ago | xtalks.com | Ayesha Rashid

The FDA has approved Ibtrozi (taletrectinib) for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Developed by Nuvation Bio, taletrectinib is a next-generation oral tyrosine kinase inhibitor (TKI) designed to target cancers driven by ROS1 gene fusions. The fusions are more common in younger patients and those who have never smoked, and are frequently associated with brain metastases.
FDA Approves Zusduri as First Non-Surgical, Chemoablative Option for Recurrent Bladder Cancer Subset

1 week ago | xtalks.com | Ayesha Rashid

The FDA has approved UroGen Pharma’s mitomycin intravesical solution, now marketed as Zusduri, for the treatment of adult patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The decision marks a significant milestone as Zusduri becomes the first FDA-approved non-surgical, chemoablative therapy for this specific bladder cancer population.
Merck’s Enflonsia Gets FDA Nod for Infant RSV Protection to Rival Sanofi and AstraZeneca’s Beyfortus

2 weeks ago | xtalks.com | Ayesha Rashid

The FDA has approved Merck’s Enflonsia (clesrovimab-cfor), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants born during or entering their first RSV season. The once-per-season injection offers a new option to safeguard infants from RSV-related illness, a major cause of pediatric hospitalizations in the US.
Incyte’s Zynyz Wins FDA Approval as Single and Combo Therapy for Anal Cancer

3 weeks ago | xtalks.com | Ayesha Rashid

The FDA has approved Zynyz (retifanlimab-dlwr) for the treatment of adults with squamous cell carcinoma of the anal canal (SCAC). The approval includes its use in combination with carboplatin and paclitaxel for first-line treatment of inoperable locally recurrent or metastatic SCAC, as well as monotherapy for patients with disease progression on or intolerance to platinum-based chemotherapy.
Medtronic to Spin Off Diabetes Division Amid Strategic Refocus

3 weeks ago | xtalks.com | Ayesha Rashid

Medical device giant Medtronic PLC has announced plans to separate its diabetes business into an independent, publicly traded company within the next 18 months. Medtronic said the move will allow it to concentrate on its core segments — cardiovascular, neuroscience and surgical devices — while enabling the diabetes unit to pursue growth opportunities more effectively.
Xtalks Clinical Edge™ Issue 5 Preview: How Biotech & Pharma Leaders Are Accelerating Trial Innovation

3 weeks ago | xtalks.com | Vera Kovacevic

As we prepare to release Issue 5, the next edition of Xtalks Clinical Edge™, our focus remains on the future of clinical trials — offering expert insights, exclusive interviews and strategies to drive innovation in clinical research. With a highly engaged audience of over 86,000 clinical trial professionals, the magazine is a trusted platform for thought leadership at the intersection of science, technology and patient care.
Which Region Is Leading the Way in Life Sciences Innovation?

4 weeks ago | xtalks.com | Vera Kovacevic

As the global life sciences industry continues to evolve, regions around the world are vying for leadership in biotech, pharma, medical devices and digital health. North America has long been a hub for innovation, with strong investment ecosystems and top-tier research institutions. Meanwhile, Europe’s regulatory rigor and public-private partnerships have made it a formidable player, and Asia-Pacific is rapidly advancing with significant government backing and a growing clinical trial footprint.
Radiopharmaceuticals and the Future of Nuclear Medicine with RadioMedix CEO Dr. Ebrahim Delpassand - Episode 209

1 month ago | xtalks.com | Ayesha Rashid

In this episode, Ayesha speaks with Ebrahim S. Delpassand, MD, Founder and CEO of RadioMedix, a company developing innovative radiopharmaceuticals for cancer diagnosis, monitoring and treatment. With a focus on both PET imaging and therapeutic radiopharmaceuticals labeled with alpha and beta emitters, RadioMedix is helping to shape the future of precision oncology. Dr. Delpassand brings a wealth of expertise as a board-certified nuclear medicine physician and a seasoned healthcare entrepreneur.
Type 1 Diabetes Clinical Research: The Science of Regenerative Therapeutic Cell Technology

1 month ago | xtalks.com | Vera Kovacevic

Diabetes affects hundreds of millions worldwide — currently, about 537 million people live with the condition, with projections reaching nearly 643 million by 2030. These figures underline the urgency for novel and more effective treatment strategies, particularly for type 1 diabetes (T1D). Although T1D accounts for only about 5% to 10% of all diabetes cases, its onset at a young age and the need for lifelong management present unique challenges.
How Digital Endpoints Are Redefining Clinical Research Strategies

1 month ago | xtalks.com | Vera Kovacevic

Digital health is reshaping clinical research and care delivery by offering more comprehensive insights into patient health. In traditional clinical trials, endpoints — measurable outcomes such as lab results, imaging studies or clinical assessments — are collected during scheduled visits at the clinic. In contrast, digital endpoints are derived from data captured continuously or intermittently through digital health technologies (DHTs), often outside of a clinical setting.