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Cell and Gene Therapy
Q² Solutions and IQVIA, Tasso | October 07, 2022
Q² Solutions, a wholly owned subsidiary of IQVIA and a leading global clinical trial laboratory services organization, today announced the launch of the first self-collection safety lab panel for U.S. clinical trial participants by a leading global clinical trial laboratory. Developed in collaboration with Tasso Inc, a leader in clinical-grade blood collection solutions, this unique offering combines industry leading laboratory services, patient focused logistics and cutting-...
Cell and Gene Therapy, Industrial Impact
Rocket Pharmaceuticals, Inc | February 09, 2023
On February 7, 2023, Rocket Pharmaceuticals Inc., a renowned late-stage biotech firm advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet needs, announced that FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, the company's investigational adeno-associated virus (AAV)-based gene therapy for Danon Disease, a life-threatening genetic cardiac disease with no disease-altering therapies available. RMAT s...
Industry Outlook
PRNewswire. | July 03, 2023
Cresilon, Inc. a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for Cresilon Hemostatic Gel™ ("CHG™"). This marks Cresilon's first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company's global mission to transform wound care. CHG™ util...
MedTech
Applied StemCell Inc. | August 30, 2022
Applied StemCell, Inc. a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, today announced the expansion of its Current Good Manufacturing facility. ASC has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/Q...
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