BioSpace News Archive

A new meta-study report commissioned by Holland Bioplastics, an association advancing bioplastics knowledge worldwide, concludes that the fundamental characteristics of polylactic acid (PLA), a biobased polymer made entirely from fermented plant sugars, and the hydrolysis process indicate that PLA does not produce persistent microplastics.

Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, has obtained FDA clearance for the Clarius OB AI fetal biometric measurement tool, improving access to obstetrical (OB) prenatal monitoring and care in resource-limited areas.

NeuroOne Medical Technologies Corporation today announced that the OneRF Ablation System was recently used at a prestigious hospital located in Jacksonville, Florida to successfully complete five ablations in one patient.

Samsung Bioepis Co., Ltd. issued its 2024 sustainability report, underscoring its progress toward building more sustainable and socially responsible practices in access to medicines, R&D innovation, and product quality and patient safety.

3X4 Genetics, leader in the field of genetics-based health, announced a partnership with The Metabolic Terrain Institute of Health to serve as the innovative nonprofit’s genetics provider.

Actym Therapeutics, pioneering a new drug modality to treat solid tumors, announced the appointments of Mary J. Janatpour, PhD, as Chief Scientific Officer and Shouryadeep “Deep” Srivastava, MD, PhD, as Senior Vice President of Clinical Development.

Hyperfine, Inc. announced that two presentations on the clinical utility of portable ultra-low-field MRI for Alzheimer’s disease monitoring have been accepted in the developing topics poster sessions at the upcoming 2024 Alzheimer’s Association International Conference, July 28–August 1 in Philadelphia.

AgileMD, Inc., an AI-powered clinical decision support company, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance for its eCART Clinical Deterioration Suite.

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) is sufficiently complete to permit a substantive review. The FDA has assigned the application for a Prescription Drug User Fee Act (PDUFA) target action date of February 8, 2025.

Ethris GmbH announced preliminary positive data from its Phase 1 dose escalation clinical trial evaluating the safety, tolerability, and target engagement of lead mRNA candidate ETH47 encoding interferon lambda, in healthy participants.