Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the U.S. Food and Drug...
After a hectic month, the FDA’s calendar appears to be easing up a bit. In the next two weeks, the regulator is facing just three major target action dates, including one potential CAR-T therapy approval that could push the class into earlier lines of treatment for...
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LB-P8, LISCure Biosciences’ investigational drug for the treatment of primary sclerosing cholangitis (PSC), a rare, chronic, cholestatic liver disease with significant unmet...
In a significant advancement for retinitis pigmentosa treatment, Nanoscope Therapeutics announced positive outcomes from its Phase IIb trial of MCO-010, a pioneering gene therapy, on Tuesday. The company is now gearing up to seek FDA approval later this year, marking...
In January, the FDA published, “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products: Guidance for Industry.” To find out how this guidance impacts the CAR-T industry, GEN talked with Klara Sochorová, PhD, senior quality compliance...
