The Food and Drug Administrationhas granted Molecular Biosystems (MBI) an "approvable letter"for its Albunex ultrasound contrast agent, the San Diego pharmaceuticaldeveloper reported last week. The letter outlines some final requeststhat, once
The Food and Drug Administrationhas granted Molecular Biosystems (MBI) an "approvable letter"for its Albunex ultrasound contrast agent, the San Diego pharmaceuticaldeveloper reported last week. The letter outlines some final requeststhat, once met, will mean that the agent fulfills all requirementsfor final FDA approval. If approved, Albunex would be the firstultrasound imaging agent cleared for commercialization in theU.S.
MBI indicated that most of the requests were minor, relatingto labeling and other specifications, and the firm will respondto them "in the next few days." The agency has alsoasked that MBI conduct postapproval studies on any adverse deviceeffects (ADEs) of Albunex. MBI indicated that all ADEs of Albunexfound during clinical trials were minor and resolved without treatment.
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.