Abstracts presented at ASCO GU examined whether the radioligand therapy impacts or is affected by ARPIs or chemotherapy.

Researchers will test the cell therapy in a dozen patients with CD19-expressing blood cancers, including diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia.

NEW YORK – Hepion Pharmaceuticals has acquired the rights to develop Cirna Diagnostics' circulating tumor RNA (ctRNA) biomarker assay that can detect early, high-risk hepatocellular carcinoma, the ...

The company is a spinoff of Avidity Biosciences, which was acquired by Novartis. The formation of the new firm was a condition of that acquisition.

In some cases, drugmakers have accused the FDA of reversing course on earlier feedback. Based on engagements with the agency, ...

The agency and the firm have agreed on certain risk mitigation measures for the MAGNITUDE and MAGNITUDE-2 trials of nexiguran ziclumeran.

The firm has four clinical-stage pipeline candidates using its conditionally active biologic antibody technology.

The FDA said it could not agree to an approval path for AMT-130 based on Phase I/II data and recommended UniQure run a randomized, controlled study.

The therapy shrunk tumors in 46 percent of patients in a Phase I trial and showed strong PSA responses at the recommended dose.

The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...

Researchers are evaluating the P-CARE model, which integrates results from a blended genome-exome sequencing assay and family ...

The recommendation is based on results from 77 patients with pediatric low-grade glioma harboring a BRAF fusion or rearrangement or BRAF V600 mutation.