Tag: FDA
ATCC Awarded Two Contracts from Gennova Biopharmaceuticals for the Continued Development of Cell Banks...
ATCC, the world’s premier biological materials management, and standards organization announced that it has been awarded two contracts from Gennova Biopharmaceuticals Limited, on behalf of the U.S. Food and Drug Administration (FDA), to continue its work with the biotechnology...
Infinity BiologiX and Roylance Pharma Rebrand as “Sampled”
Infinity Biologix (IBX) and Roylance Pharma just announced the rebrand of both organisations as "Sampled". Sampled is a next-generation laboratory that unlocks valuable data from any biological sample. By focusing on the genetic causes of common, complex diseases, Sampled aims...
BioLife Solutions Positive About FDA’s Proposed New Policies To Advance Cell And Gene Therapies
BioLife Solutions, Inc., has announced that the company expects to benefit from the new policies to advance the development of safe and effective cell and gene therapies as set forth in a statement issued by the U.S. Food and...
FDA Calls Out Companies Marketing Stem Cell Products Without BLA Approval
The U.S. Food and Drug Administration has warned Genetech,
Inc. of San Diego, California and its president, Edwin N. Pinos for marketing
stem cell products without FDA approval and for significant deviations from
current good tissue practice (CGTP) and current good manufacturing...
FDA Clearance For Cesca Therapeutics’ Automated Cord Blood Stem Cell Collection Solution
Cesca Therapeutics Inc., has announced that its device subsidiary, ThermoGenesis® Corp., has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its proprietary AXP® II AutoXpress® Platform (AXP II) for clinical blood banking. Cesca Therapeutics Inc., founded...
Cellenkos Cleared By FDA To Start Phase I Trials Of Allogeneic Cord Blood-Derived Regulatory...
The United States Food and Drug Administration (FDA) has recently cleared the Investigational New Drug (IND) application of Cellenkos, Inc. The company can now proceed with a phase I clinical trial of its IND first-in-class CK0801, allogeneic cord blood-derived...
Mustang Bio And FDA Complete Pre-IND Meeting For MB-102 (CD123 CAR-T)
Mustang Bio, Inc., a Fortress Biotech Company, headquartered in the greater New York City area, is a clinical‐stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to leverage the patient’s own immune system...
FDA Grants Nohla Therapeutics’ Cell Therapy Dilanubicel Orphan Drug Designation for HSCT
Nohla Therapeutics, headquartered in Seattle, is a leading developer of “off-the shelf” cell therapies for patients with cancer and other diseases. Nohla’s proprietary notch ligand technology platform serves as the foundation for its ongoing clinical, preclinical and discovery programs....
