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1250 articles, sorted by publication time.
Among nearly 500 previously treated patients with metastatic pancreatic ductal adenocarcinoma, the oral RAS inhibitor increased median survival from 6.7 months in the chemotherapy group to 13.2 months; the US FDA has accepted the application, but the durability of efficacy and complete safety data still require follow-up.
TIXiMED launches a 28-day Phase 1 trial in healthy adults, paving the way for a study in patients with type 1 diabetes; whether the new mechanism can protect pancreatic beta cells remains far from clinically proven.
A trial involving 687 participants showed that once-daily ralinepag can delay disease worsening and improve measures of cardiac stress and walking distance; however, the high discontinuation rate and the exclusion of some trial data from China remain key points of regulatory review.
Across 100 multidisciplinary simulations involving multiple consecutive visits, Google’s AMIE produced more precise, guideline-aligned care plans; however, outperforming physicians in text-based scenarios does not yet prove that it can safely care for real patients.
Three final guidances call for trial design to return to the scientific risks of each disease and drug, reducing exclusion criteria that lack a supporting rationale. The reforms could make study populations more representative of real-world patients, but the recommendations themselves are not legally binding.
mFLUSIVA becomes the first seasonal mRNA flu vaccine approved in the United States; a large trial showed about 27% fewer cases than with a standard-dose vaccine, but clinical benefit in people aged 65 and older still requires confirmation in follow-up research.
A randomized trial of 509 people showed that the two-drug regimen met the non-inferiority criterion versus the three-drug regimen for viral suppression at 48 weeks. The results support treatment simplification, but cannot yet be interpreted as showing better safety or suitability for all patients.
Sobi is supporting lacutamab’s move into late-stage development with a $75 million upfront payment and milestone payments; the deal removes a funding bottleneck, but accelerated approval still depends on regulatory review and a confirmatory trial.
The first three participants worldwide have received this targeted alpha-particle therapy; it aims to concentrate radiation more within tumors and accelerate renal clearance, but it has so far entered only dose exploration, with no human efficacy or safety results yet available.
The research team simultaneously rewrote the KIT epitope and the BCL11A regulatory region in hematopoietic stem cells, allowing therapeutic cells to evade antibody-mediated clearance and gradually increase in vivo. The mouse results open a path toward low-toxicity transplantation, but multiple safety and manufacturing hurdles remain before human application.
A UK medical team has administered subretinal gene therapy to one eye in three children and adolescents in an attempt to restore a normal BBS10 gene; this first-in-human use remains a limited, physician-led treatment program and cannot yet be regarded as a successful clinical trial or an approved therapy.
Following a strategic review, Arovella has focused its resources on its iNKT cell platform. Its first CD19-targeted candidate is about to enter a Phase 1 trial, but questions about safety, persistence, and preliminary anticancer activity still await human data.