Tag: lesions

Sanofi’s SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration

Payer coverage for Emrosi™ now available for 65% of commercial lives, up from 29% in May 2025

- Presentations highlight clinically meaningful reductions in BMI in patients with acquired hypothalamic obesity –

MELBOURNE, Australia and INDIANAPOLIS, July 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that its next-generation PSMA¹ PET² imaging agent, Gozellix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).

-  500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia

Garching / Munich, Germany, and Lausanne, Switzerland - June 23, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm, a Swiss-based, global biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, today announced that the first patient was imaged in a new study arm of a five-part, Phase 1/2 clinical trial (formerly GaLuCi™) (NCT05706129) evaluating the theranostic pair ITM-94/ITM-91 for identification and treatment of patients who have unresectable, locally advanced or metastatic solid tumors. As a new component of a broad clinical development plan for ITM-91/ITM-94, Part D of the trial will evaluate the effectiveness of ITM-94 in classifying indeterminate renal mass as either ccRCC or non-cancerous.