Drugs

Fast Track for Myosin Glioblastoma Drug

DA has granted a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating glioblastoma (GBM), one of the most aggressive and treatment-resistant brain cancers. “This fast track designation validates our conviction that MT-125 has the potential to offer an entirely novel treatment approach to patients with even the most aggressive forms of glioblastoma,” Myosin Therapeutics CEO Courtney Miller is quoted in a press release as saying.

MT-125 is described as a first-in-class dual inhibitor of non-muscle myosin IIA and IIB — proteins known as cellular “nanomotors” that drive tumor proliferation and invasion. By targeting both, the company says, the drug aims to block key mechanisms that enable GBM growth and spread, while also enhancing the effectiveness of radiation therapy.

A Phase 1-2 trial of MT-125 in patients with glioblastoma has been cleared to begin (ClinicalTrials.gov identifier: NCT07185880), evaluating the therapy’s safety, pharmacokinetics, and preliminary anti-tumor activity. Previously, FDA granted the therapy an orphan drug designation for malignant gliomas, including GBM.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome