Curated news and analysis on clinical trials, drug approvals, and medical research.
Atara Biotherapeutics announced a Type A meeting with the FDA to discuss the Complete Response Letter for tabelecleucel's Biologics License Application, held by partner Pierre Fabre Pharmaceuticals.
India's pharmaceutical industry, valued at Rs. 5.41 lakh crore in 2025, is transitioning from a generics powerhouse to an innovation-driven sector focused on biosimilars, complex formulations, and global R&D capabilities.
Study finds advanced melanoma patients with sufficient vitamin D levels showed better response rates and longer survival when receiving anti-PD-1 immunotherapy compared to those with low vitamin D status.
Cidara Therapeutics is approaching a critical interim analysis of its Phase 3 ANCHOR trial for CD388, an influenza prophylactic candidate. The results will determine whether the company proceeds with its planned Biologics License Application.
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
Researchers discovered that adding three common amino acids to lipid nanoparticles dramatically improves mRNA and CRISPR gene editing delivery, boosting efficiency up to 20-fold and raising gene editing success rates from 25% to nearly 90%.
Arcturus Therapeutics completed three 28-day inhaled mRNA cohorts for cystic fibrosis that were well-tolerated and showed early biological signals. The company is preparing a 12-week Phase 2 study with tightened eligibility criteria and expanded enrollment into Europe and the Middle East.
BioVersys has dosed the first patient in a Phase 2b trial evaluating alpibectir-ethionamide (AlpE) in combination with first-line TB drugs, following promising Phase 2a results published in the New England Journal of Medicine.
New AI platforms are emerging to address rare disease diagnosis and epidemiology, as global costs reach up to $8.6 trillion annually affecting 300 million patients worldwide across more than 7,000 distinct conditions.
Federal vaccine advisers have dropped a plan to reconsider mRNA COVID-19 vaccine recommendations amid Republican concerns about midterm election impacts. The committee maintains its September 2025 decision on shared clinical decision-making.
Scientists have developed two breakthrough approaches to dramatically enhance gene editing and mRNA therapy delivery: a simple amino acid supplement that increases CRISPR efficiency to nearly 90 percent, and a self-replicating CRISPR system that spreads between cells like a virus.
Solid Biosciences has secured FDA alignment on a registration pathway for its Duchenne muscular dystrophy gene therapy SGT-003, with 36 patients dosed to date showing no drug-induced liver injury, myocarditis, or other serious adverse events reported with competing therapies.
New market reports forecast significant expansion in CAR T-cell therapy, US pharmaceutical drug delivery, and healthcare nanotechnology sectors, driven by chronic disease prevalence and technological advances.
Brainstorm Cell Therapeutics announced a $1 million private placement at a premium to market price to support its upcoming Phase IIIb trial of NurOwn stem cell therapy for amyotrophic lateral sclerosis.
Researchers identify speech latency as a biomarker to enrich schizophrenia clinical trials, while a separate study finds clozapine more effective than alternatives for patients who fail initial antipsychotic treatment.
Pembrolizumab-based regimens demonstrated significant survival improvements in two separate trials: KEYNOTE-B15 for muscle-invasive bladder cancer and KEYNOTE-B96 for platinum-resistant ovarian cancer, with FDA approval granted for the ovarian cancer indication.
The global precision medicine market reached $82.1 billion in 2025 and is expected to grow to $179.4 billion by 2034. Researchers emphasize that precision nutrition interventions must demonstrate cost-effectiveness to deliver patient benefits.
New research from 18 countries shows COVID-19 vaccination during pregnancy, particularly with booster doses, significantly reduces the risk of preeclampsia and other serious complications for both mothers and babies.
The FDA is accelerating its review of daraxonrasib, a targeted therapy for pancreatic cancer, under a new pilot program that could reduce approval time from 10-12 months to one to two months.
Merck announced multiple data presentations at the 2026 ASCO GU Cancers Symposium, including results from trials evaluating pembrolizumab combinations in muscle-invasive bladder cancer and renal cell carcinoma.
