Curated news and analysis on clinical trials, drug approvals, and medical research.
Transposase systems are emerging as efficient alternatives to CRISPR-Cas9 for gene editing in biopharmaceutical manufacturing and plant breeding, with studies showing up to 90% efficiency and heritability rates while offering advantages in size and integration capabilities.
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
Three new CRISPR-based therapies show promise for treating heart failure through mitochondrial enhancement, cystic fibrosis via lipid nanoparticle gene insertion, and elevated cholesterol with single-dose gene editing targeting ANGPTL3.
Novo Nordisk dismissed its patent infringement lawsuit against Hims & Hers after the companies reached an agreement to sell branded Wegovy and Ozempic through the Hims platform. The settlement ends a dispute that began when Hims planned to offer a cheaper off-brand version of Wegovy.
Veru Inc. has enrolled the first patient in its Phase 2b PLATEAU clinical trial evaluating enobosarm combined with semaglutide for weight loss in older patients with obesity. The study will assess enobosarm's ability to preserve lean mass and physical function while augmenting fat loss.
AbbVie announced positive Phase 1 results for ABBV-295, a long-acting amylin analog for obesity treatment, showing clinically meaningful weight loss with favorable tolerability across all dose levels tested.
New real-world effectiveness data presented at RSVVW'26 demonstrate that GSK's Arexvy RSV vaccine was associated with a 75.6% reduction in RSV-related hospitalizations among adults aged 60 and older, with exploratory findings suggesting potential benefits for cardiovascular and respiratory complications.
New research demonstrates machine learning can optimize drug dosing, identifies biomarkers of treatment response, and validates prognostic criteria for long-term kidney survival in pediatric lupus nephritis patients.
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
A study published in Nature Microbiology demonstrates that a defined consortium of 15 gut bacterial species derived from immunotherapy responders significantly enhances anti-PD-1 treatment efficacy in mouse models of non-small-cell lung cancer.
Grail's NHS-Galleri trial of 142,000 participants failed to achieve statistically significant reduction in late-stage cancer diagnoses, though secondary endpoints showed four-fold improvement in overall cancer detection rate. Stock fell 48% following the announcement.
FDA elevated OS Therapies' Type D meeting to Type B pre-BLA meeting for OST-HER2 in osteosarcoma, signaling transition to Accelerated Approval discussions. Clinical data submission targeted for end of Q1 2026.
ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.
Pfizer's tilrekimig met its primary endpoint in a mid-stage eczema trial and will advance to late-stage testing. Separately, oral remibrutinib demonstrated rapid efficacy in treating peanut allergy in a phase II study.
Sequel Med Tech and Senseonics announced full U.S. availability of the twiist Automated Insulin Delivery System integrated with the Eversense 365 CGM, the world's only one-year continuous glucose monitor, for people with type 1 diabetes.
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
OS Therapies progresses toward Accelerated Approval for OST-HER2 in osteosarcoma, with FDA elevating meeting status and global regulatory submissions on track for Q1 2026.
The FDA has accepted a supplemental new drug application for aminolevulinic acid hydrochloride plus red light therapy for superficial basal cell carcinoma, with a decision date set for September 28, 2026.
Precision BioSciences receives FDA Fast Track designation for PBGENE-DMD, a gene editing therapy for Duchenne muscular dystrophy designed to treat patients with mutations in exons 45-55.
Precision BioSciences announced FDA Fast Track designation for PBGENE-DMD, a first-in-class gene editing therapy for Duchenne muscular dystrophy targeting mutations in exons 45-55, representing up to 60% of DMD patients.
