BioSpace News Archive

The Center for Breakthrough Medicines (CBM) and jCyte today announced a multi-year manufacturing agreement wherein CBM will be the primary manufacturer of jCyte’s U.S. Food & Drug Administration’s Regenerative Medicine Advanced Therapy (RMAT) designated cell therapy, jCell.

Persephone Biosciences Inc., a synthetic biology company reimagining patient health through the development of microbiome-based medicines, today announced that the first participant has been enrolled in the ARGONAUT clinical study to determine the impact of gut microbiome composition and function on the immune system and the efficacy of cancer treatment.

Nexalin Technology, Inc. (the “Company” or “Nexalin”) today announced the closing of its previously announced initial public offering of 2,315,000 units consisting of 2,315,000 shares of its common stock and 2,315,000 accompanying warrants to purchase 2,315,000 shares of common stock.

For the past several months, the U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, including the U.S. Department of Health and Human Services and the U.S. Department of Agriculture, to expand consumer access to infant formula products, while also ensuring that these products meet the agency’s safety, nutrition and quality standards.

Hoag’s Pickup Family Neurosciences Institute is initiating a clinical trial for a promising new investigational treatment for Alzheimer’s disease (AD).

In May 2022, FDA Commissioner Robert M. Califf, M.D., asked that I conduct an internal agency review of the agency’s actions related to multiple reports of Cronobacter illness in infants, the Abbott’s infant formula manufacturing plant in Sturgis, Michigan, and confounding issues that led to a shortage of infant formulas.