FDA can chose to place the IND on clinical hold or could terminate the IND based on their review. If an IND is placed on clinical hold, the hold may be removed if the sponsor addresses the deficiencies, but clinical trials may not progress until the clinical hold is removed. In July ...
Following positive outcomes from three early clinical trials, the FDA granted approval of GO in 2000, specifically for the treatment of patients with CD33-positive AML aged over 60 who were ineligible for cytotoxic chemotherapy [10]. However, safety concerns surfaced during the Southwest Oncology ...
Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of topical products, ...
In clinical trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of contr...
Building on icaritin’s success, a novel anti-tumor drug, SNG1153, is currently in Phase I clinical trials in both China and the United States. This drug introduces a novel modification by replacing the methoxy group at C4 on the benzene ring with a trifluoromethyl group, potentially offering...
Previous studies have shown that assessing enrichment of Aβ plaque load is particularly relevant in assessing the feasibility of clinical trials in enriched amyloid-positive patients with AD, where separate clinical criteria appear to lead to serious misclassification [28]. This is in line with the...
“Transparent Labs Whey Protein Isolate packs in the protein without unnecessary fluff,” according to Chelsea Rae Bourgeois, RDN, a registered dietitian. “Each scoop provides 28 grams of protein and minimal amounts of carbs and fat.” Since this is a whey isolate, the formulation has been fi...
John D. Loeser Award Lecture: size does matter, but it isn’t everything: the challenge of modest treatment effects in chronic pain clinical trials. Pain. 2020;161(1)(suppl 1):S3-S13. doi:10.1097/j.pain.0000000000001849 PubMedGoogle ScholarCrossref See More About Neurology ...
FRUZAQLA Plus Best Supportive Care Demonstrated Significant Improvements in Overall Survival, with Corresponding Improvements in Progression Free Survival, Versus Placebo Plus Best Supportive Care in Two Phase 3 Clinical Trials FRUZAQLA Demonstrated a Manageable Safety ...
RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. In Part 2, the primary endpoint is investigator-assessed PFS...