Regulatory Affairs

      Kiromic BioPharma Announces Company Will Directly Submit Amended IND for Procel™ to the FDA in Second Half of 2022

      HOUSTON--(BUSINESS WIRE)--Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the “Company”), a clinical-stage fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) and...

      PharmaCyte Biotech Updates Status of Investigational New Drug Application to FDA

      LAS VEGAS--(BUSINESS WIRE)--PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation...

      Bayer Receives FDA Fast Track Designation for asundexian Stroke Program

      WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334)...

      Eureka Therapeutics Receives Orphan Drug Designations for Treatment of Hepatocellular Carcinoma (HCC) With ARTEMIS® T Cells

      EMERYVILLE, Calif.--(BUSINESS WIRE)--Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumors, today announced that the U.S. Food and...

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