The decision reaffirming the FDA's oversight authority over cell and gene therapy products was praised by the International ...

With help from the oversubscribed financing round, the Australian firm is eyeing early 2025 for a Phase I clinical trial of its TAG-72-targeting cell therapy.

The firm will use the funding to begin a first-in-human trial of its autologous macrophage cell therapy in liver disease.

The radiopharmaceutical, already approved for SSRT-expressing GEP-NETs, may be a new option in meningioma if future research ...

The firm sees potential for AI algorithms to support drug development by screening patients for biomarkers and predicting their responses to cancer therapies.

Patients had fewer bleeds after treatment with Beqvez compared to standard treatment, but questions remain about which ...

The firm said it will discuss biomarker results, including a marked decrease in N-acetylaspartate levels and an increase in brain white matter.

Prevail will buy $350,000 worth of shares in Hemogenyx and will serve as a contract research organization for an upcoming clinical trial in pediatric leukemia.

The FDA expects to issue a decision in the first quarter of 2025, and if the agency grants approval, it will expand the biomarker-eligible population for the drug.

In a draft guidance, the institute did not recommend Orserdu, but is collecting additional data and public comments on this preliminary decision.

The clinical trial testing ATA-200 to treat a type of LGMD caused by mutations in the SGCG gene has already been cleared in Italy and France.

Researchers are planning a clinical trial after four metastatic FGFR2 fusion-positive pancreatic cancer patients responded to ...