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
The incubator anchored at the company's global headquarters in Raleighla launches alongside an inaugural partnership with Cape Fear BioCapital, a Durham-based seed-stage venture capital firm
The company said the safety profile remained consistent with earlier studies and was considered manageable
Suven has already begun planning a global Phase 3 registrational program for MDD based on the results
The study enrolled 639 patients, nearly 80% of whom had previously received a covalent BTK inhibitor
The decision was driven by results from the Phase III CAPItello-281 trial,
The regulatory decision follows promising results from RIVER-81
KIHT can now conduct clinical research for drugs and medical devices, strengthening evidence generation and healthcare innovation
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