BioSpace News Archive

International study designed to build on positive 12-month data from TROPHY1 demonstrating improvement in multiple clinical endpoints and no serious procedure-related adverse events

Brain Scientific Inc., a neurology-focused medical device and software company, has submitted a premarket 510 application to the United States Food and Drug Administration for its next generation NeuroCap™ device.

Company reaffirms near term milestones for the Mydcombi™ (MicroStat) NDA and the MicroLine presbyopia program Phase III results

Apexigen, Inc., a clinical-stage biopharmaceutical company, announced that Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview of the company at the upcoming Solebury Trout Fall 2020 Virtual Private Company Showcase.

Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups

FH Ortho Inc, a well-established innovative orthopedic medical device company, is pleased to announce the FDA clearance of Telegraph Evolution, a next generation humeral nailing system for use in proximal and/or mid-shaft humeral fractures. Chris Valois, General Manager of FH Ortho Inc said, “We are seeing a trend in the US towards humeral fracture nails and away from plating due to advancements in instrumentation and perceived improved patient outc

Nephros, Inc. (Nasdaq: NEPH), a commercial-stage company that develops and sells high performance water purification products and pathogen detection systems to the medical and commercial markets, today announced availability of DialyPath™, an assay that estimates endotoxin levels in dialysis water samples.

Kane Biotech Inc. announced that Kevin Cole will assume the role of President and CEO of STEM Animal Health Inc., a subsidiary created from the recently formed joint venture with UK-based international veterinary products company, Animalcare Group PLC .

Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that enrollment has opened and the first patient has been dosed in its randomized, double-blind Phase 1b study of CDX-0159 in patients with chronic spontaneous urticaria (CSU). CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of ce

PMV Pharmaceuticals, Inc., (Nasdaq: PMVP) a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutations, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate PC14586,