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1250 articles, sorted by publication time.
The new guidance brings common challenges scattered across review meetings, manufacturing requirements, and clinical trial design into a single roadmap. It can help new teams avoid procedural gaps, but cannot replace early communication with the FDA about individual products.
An exploratory analysis of CheckMate 77T showed that adding nivolumab can increase the preoperative ctDNA clearance rate; all patients whose postoperative molecular residual disease status changed from negative to positive experienced recurrence, but this marker is not yet sufficient to guide treatment decisions on its own.
This fluorine-18 radiotracer enables PET imaging of tau neurofibrillary tangles in the brain, adding another piece to the pathological puzzle beyond amyloid imaging. However, scan results cannot independently confirm or rule out the disease, and the timeline for availability remains unclear.
The EMA has accepted the marketing authorization application for Pfizer and Valneva’s hexavalent vaccine VLA15; the Phase 3 trial showed approximately 70% protection, but the primary analysis did not meet the prespecified statistical criterion, and acceptance does not mean approval.
A Korean team reconstructed the vascular barrier at the edge of brain tumors using patients’ tumor cells; preliminary results from three cases were consistent with their clinical courses, but prospective validation is still needed before the chip can actually be used to select drugs.
Following Fulcrum’s setback, its merger with Slate could provide funding to advance SLTE-1009 into Phase 2 trials; however, whether simultaneously blocking PACAP and VIP can outperform existing and investigational therapies will remain unanswered until human data are available.
Sirexatamab did not significantly delay disease progression in the overall patient population, but a stronger efficacy signal emerged in the high-DKK1 subgroup. This exploratory finding is shifting development toward biomarker-based selection while leaving statistical questions that must be answered by a phase 3 trial.
intismeran combined with Keytruda delayed recurrence and distant metastasis in a 1,137-patient trial, providing crucial validation for personalized cancer vaccines; however, the magnitude of benefit, overall survival, and complete safety data have yet to be disclosed.
An FDA expert panel will vote on GRAIL’s multi-cancer early detection application on September 23; the review concerns not only one product, but will also test how high a clinical evidence threshold blood-based cancer screening must clear.
The research team used artificial intelligence to screen candidate compounds, targeting the PDZ protein-interaction region of GIPC1 with a small molecule for the first time. The compound inhibited tumors and enhanced gemcitabine in preclinical models, but its safety and efficacy in humans remain unknown.
A synthetic peptide exploits acidity differences inside and outside tumors to sequentially disrupt lysosomes and cell membranes, allowing cancer cells to activate inflammatory signals before disintegrating. Mouse experiments show that it can amplify the efficacy of anti-PD-L1 therapy, but multiple hurdles remain before it can become a human treatment.
A participant in the HG302 high-dose cohort developed a severe complement and cytokine response after systemic administration and ultimately died of acute respiratory distress; the company did not disclose the event until nearly a year later, bringing dose escalation, regulation, and information transparency into focus.