NEW YORK – The US Food and Drug Administration on Wednesday granted accelerated approval to Dizal's oral EGFR inhibitor Zegfrovy (sunvozertinib) as a treatment for patients with locally advanced or ...

The study will use a companion lipid biomarker test to identify those with a poor prognosis who are potential best responders.

Using 400 real-world patient cases, the CARE platform correctly classified 99.5 percent of cases according to NCCN guidelines ...

D Molecular Therapeutics said it is streamlining operations to offset expected expenses as it accelerates the timelines for its Phase III trials.

The study also included older children and found the best outcomes in patients between 5 years and 8 years old.

The EC granted conditional approval based on activity seen in a subset of IHC 3+ HER2-positive advanced biliary tract cancer patients in a Phase II trial.

The firm hopes that ETX-636's dual mechanism inhibiting mutant PI3Kα will give it an edge over competing products on the market.

The biotech has received written agreement from the agency through the START pilot program on key aspects of its trial design for evaluating NGN-401.

After an abnormal NIPT finding in a pregnant woman, a maternal-fetal medicine doctor orders a second NIPT, against recommendations.

With an FDA IND clearance, the firm will test IKS014 as an alternative for HER2-positive solid tumor patients in the US who have relapsed on other therapies.

The firm is advancing its AI-driven multi-modal digital pathology platform as a tool for guiding clinical trial design and patient identification.

The firms are planning two clinical trials of the anti-CTLA-4 agent muzastotug in colorectal cancer and in solid tumors.