No serious treatment-related adverse events observed in first 13 patients receiving ENV-105 with AstraZeneca's Tagrisso in Phase I study.
The first-line approval is backed by results from the Phase 3 BREAKWATER trial, which demonstrated that the cetuximab–encorafenib–FOLFOX combination delivered statistically significant and clinically meaningful improvements
The majority of participants also rated the denecimig pen-injector positively, with 94.1% of 185 participants describing it as easy or very easy to use and 89.7% reporting it was quick
This, after positive FDA feedback on neuropathic corneal pain program
The potential impact of the findings is particularly significant in episodic migraine, which represents a larger patient population than chronic migraine
The treatment effect emerged early and continued to build over time, with statistically significant improvement observed as soon as Day 64 and maintained through Week 24
The results come from two Phase 1/2 trials evaluating zoldonrasib both alongside standard chemotherapy in first-line patients and in combination with daraxonrasib in previously treated disease
The company said it has engaged with China’s Center for Drug Evaluation of the National Medical Products Administration and reached preliminary alignment regarding a potential registrational study for the ENRICH approach
Newron and the FDA discussed changes required for the study to potentially restart enrollment in the United States
Following a licensing agreement signed between the company and DNDi, a Phase III clinical trial to be conducted in Brazil, Malaysia, and Thailand
The proceeds will fund the planned early third-quarter 2026 launch of the global Phase 3 SURPASS-IPF trial
The approval introduces a chemotherapy-free treatment option for patients whose follicular lymphoma has returned or failed to respond to previous therapy
The clinical-stage biotech has completed the transplantation phase of its TOL-2 study evaluating MIC-Lx, with topline efficacy and safety data expected in the first half of 2027
India has become the first market under Glenmark’s licensed territories to begin patient enrollment
At 12 weeks, EVO756 did not achieve a statistically meaningful improvement in mean change in Urticaria Activity Score over seven days (UAS7) at any dose tested
The trial will enroll approximately 468 patients
At the latest Indian Pharma Post E-Conference, leading experts highlighted the need for accredited trial sites, skilled investigators, digital ecosystems, and greater public trust
The study also met its key secondary endpoint for bone health
The investigational treatment is showing statistically significant improvements in ADHD symptoms versus placebo at week 8
The findings come from the first and only decentralized real-world study examining how HD chorea affects patients and caregivers and how treatment impacts quality of life
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