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1250 articles, sorted by publication time.
The new guidance requires research teams to provide scientific justification for blood cell count and organ function thresholds and to reassess them as drug safety data accumulate, with the aim of making later-stage trials more representative of real-world clinical populations.
In a pivotal trial of 905 people, bemnifosbuvir/ruzasvir met the primary endpoint of non-inferiority to Epclusa; patients without cirrhosis required only 8 weeks of treatment, but full data and regulatory review still lie ahead.
The deal moves CAR-T from customized cell manufacturing into the race to “complete reprogramming inside the patient”; however, Sail’s program remains at the preclinical stage, and its disease target, safety, and efficacy in humans have yet to be disclosed.
Multi-omics analysis of 63 samples shows that tumors can exhibit distinct states involving immune response, proliferation, inflammation, or metabolism, potentially offering stratification clues for immunotherapy and epigenetic therapy; however, this classification has not yet been validated in prospective clinical trials.
In a controlled experiment, GHP-88310 prevented canine distemper virus transmission through contact and shared air; treating the source of infection also shortened the infectious period by five days. However, these findings remain animal evidence from a surrogate virus and cannot be taken to mean that a measles drug is now available.
Shanghai Jiao Tong University School of Medicine is investigating the death of a young girl following an experimental base-editing treatment; animal safety warning signs, informed consent, and a long-unupdated trial record are becoming key focuses of the inquiry.
A phase 3 trial involving more than 12,000 people showed that evolocumab can reduce major cardiovascular events in people who have not yet had a heart attack or stroke; however, this use still awaits a final decision from the European Commission.
Lytenava has become the first bevacizumab formulation in the United States manufactured specifically for intravitreal injection, adding a formally regulated option for wet macular degeneration; however, results from two comparative trials were inconsistent, and its clinical positioning will also depend on price, reimbursement, and real-world performance.
The early-stage NEOVACC trial turns patients’ tumor mutations into personalized vaccines administered in combination with immunotherapy; this ten-person study will first seek to determine whether rapid manufacturing can safely elicit a precise anticancer immune response.
The software turns routine coronary computed tomography images into indicators of inflammation and mortality risk; regulatory clearance opens the door to clinical use, but whether it can truly improve treatment decisions and patient outcomes remains to be answered by prospective studies.
First Read seeks to interpret an entire chest X-ray at once and draft a report; its Breakthrough Device designation covers only four life-threatening findings, and it still has a way to go before validating more than 100 interpretation capabilities and obtaining marketing authorization.
EZPLAZ can be stored at 2–25°C for 12 months, opening up a new option for ambulance transport, remote medical care, and battlefield transfusion; however, early human data are limited, and the FDA requires a Phase 4 trial to monitor thrombotic risk.