The groups are calling for genotype-informed prevention and treatment strategies, APOE stratification in clinical trials, and related public policies.
The firm is preparing to submit supplemental NDAs for Vyondys 53 and Amondys 45 with results from a failed confirmatory trial and real-world data.
After a meeting with the FDA, the company believes the agency is aligned with its development plan to start a Phase III registrational trial in CLDN 18.2-, PD-L1-positive tumors.
The companies have identified an initial set of genetic biomarkers to predict drug response and will validate the findings in ...
BobcatBio brought on the contract development and manufacturing organization to support manufacturing for ongoing Phase I studies in lymphoma and solid tumors.
The Shenzhen, China-based biotech plans to launch a Phase I trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026.
A Diaceutics report looks at when in the diagnosis, testing, and treatment process NSCLC patients lose out on access to precision medicine.
The government hopes to limit cases in which NICE determines a treatment isn't cost effective after the MHRA has deemed it ...
BriGene Biosciences supported Grit with technology transfer, manufacturing, and regulatory requirements for the IND for GT307.
Early clinical data indicates the treatment leads to dose-dependent increases in functional AAT protein, which is altered in the condition.
In its third phase, the Diagnostics Accelerator will support the development of multi-marker panels leveraging digital and AI tools that can accelerate precision treatments.
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