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Diatide nets milestone for AcuTect
Peptide-based imaging agent developer Diatide has announced that it has received an approvable letter from the Food and Drug Administration for its AcuTect technetium-labeled agent for the imaging of acute venous thrombosis in the lower extremities. The
Peptide-based imaging agent developer Diatide has announced that it has received an approvable letter from the Food and Drug Administration for its AcuTect technetium-labeled agent for the imaging of acute venous thrombosis in the lower extremities. The letter arrived exactly six months following the submission of the new drug application (NDA) to the FDA (SCAN 9/3/97).
The letter indicates that Diatide's NDA will be approved once the company clarifies certain details and formally agrees to specific postapproval requirements, according to the Londonderry, NH-based firm. Diatide expects to begin to co-market AcuTect in the U.S. with its corporate partner Nycomed Amersham immediately following approval of the agent.
New Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.
