BioSpace News Archive

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Aurora Spine Corporation, a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announces that it has granted options to acquire 1,000,000 common shares of the Company to Trent J. Northcutt, President & CEO.

Bayer is voluntarily recalling one lot of Vitrakvi® Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level.

BioMimetix JV, LLC, a clinical-stage biotechnology company developing metalloporphyrins, a novel drug class for the treatment of cancer patients, today announced the presentation of encouraging data from its Phase 2 study of lead candidate, BMX-001, for the treatment of high-grade glioma (HGG) at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting.

ACG Engineering, a division of ACG, a leading supplier of integrated manufacturing solutions to the global pharmaceutical and nutraceutical industries, is delighted to launch its new SMARTCOATER X•ONE series, the company’s fastest tablet coater to date.

Cofactor Genomics, the company bridging the precision medicine gap, today announced successful validation of the OncoPrism immunotherapy predictive diagnostic assay, enabling physicians to use the test to help guide treatment decisions for patients with metastatic or recurrent squamous cell carcinoma of the head and neck (HNSCC).

Paragonix Technologies, a pioneer in organ transplant technologies and organ procurement services, has successfully completed the world’s first-in-human case utilizing its newest donor lung preservation technology, the BAROguard™ Donor Lung Preservation System, which received FDA 510(k) clearance in August 2023.

Genethon today announced The Lancet Neurology published online preliminary results of a clinical trial conducted by Astellas Pharma using a gene therapy developed by Genethon for X-linked myotubular myopathy, a rare genetic muscle disease affecting 1 in 50,000 newborn boys.