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FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent

Imaging Technology

mtaschetta-millane Wed, 07/24/2024 - 11:17 July 24, 2024 — Telix Pharmaceuticals Limited announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit ("Kit") for the preparation of PSMA-PET imaging[1] for prostate cancer.

Imaging 105
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AuntMinnie 2007: Gadolinium: A 'necessary factor' in the development of NSF?

AuntMinnie

How are imaging experts and others handling NSF? The FDA asked physicians to use alternative methods to image patients with moderate to end-stage renal disease whenever possible. Imaging is generally required for organs other than the kidneys and MR is the first-line imaging exam. Clearly, a major problem is at hand.

Disease 290