An ongoing Phase III trial aims to further evaluate the drug's clinical efficacy in reducing seizures and affecting behavior and cognition.

The group has already helped pass bills in Arkansas and Oklahoma, and is supporting bills introduced in Florida, Mississippi, and Tennessee.

Two former FDA veterans are worried that a "firewall" between politics and scientific regulatory decisions has been breached, risking the agency's reputation and leadership.

The firm believes that clinical data generated to date from two patients may be sufficient to support accelerated approval of PM359.

NEW YORK – T-Knife Therapeutics plans to begin a clinical trial this year of its PRAME-targeting armored T cell receptor (TCR) therapy, after the company confirmed on Tuesday that the European ...

NEW YORK – Hutchmed on Wednesday said it started a Phase I/IIa trial of its antibody-targeted therapy conjugate (ATTC) HMPL-A580 in patients with unresectable, advanced or metastatic solid tumors.

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

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.

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

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.

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.