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Catalent Expands AAV Gene Therapy Partnership with Taysha Gene Therapies, Securing Exclusive Commercial Manufacturing for Rett Syndrome Treatment TSHA-102
Pharma Manufacturing USA Overview Taysha Gene Therapies and CDMO Catalent have expanded their strategic partnership, designating Catalent as the exclusive commercial manufacturer for TSHA-102, an AAV-based gene therapy for Rett syndrome,... -
Vertex Pharmaceuticals Secures FDA IND Approval for iPSC-Derived Type 1 Diabetes Therapies, Boosts 2026 Revenue Forecast
Vertex Pharmaceuticals USA Overview Vertex Pharmaceuticals announced robust Q2 2026 financial results and significantly raised its full-year revenue guidance, propelled by key pipeline advancements. The company secured FDA Investigationa... -
Advancements in Cell and Gene Therapy Manufacturing: Automation, Cost Reduction, and Scalability Revolutionize Patient Access
Bioprocessing Summit Europe International Overview The cell and gene therapy (CGT) manufacturing sector faces significant operational challenges, including high costs and scalability constraints, particularly due to raw material variabil... -
Allogeneic CAR T-Cells: The Off-the-Shelf Revolution in Cancer Immunotherapy Manufacturing
Liv Hospital Turkey Overview Autologous CAR T-cell therapies face significant hurdles in scalability and turnaround time, limiting their broad accessibility. The industry is rapidly shifting towards off-the-shelf allogeneic CAR T-cells, ... -
U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designations: 168 Publicly Announced by 2026, Accelerating Transformative Therapies in Oncology and Rare Diseases
BioInformant USA Overview According to BioInformant, as of August 2026, the U.S. FDA has publicly announced 168 Regenerative Medicine Advanced Therapy (RMAT) designations. These designations are granted to cell and gene therapy products ... -
Intellia Therapeutics Reports Positive Phase 3 HAELO Data for lonvo-z in HAE and Resumes Nex-z ATTR Phase 3 Enrollment
Intellia Therapeutics USA Overview Intellia Therapeutics announced positive Phase 3 HAELO clinical data for lonvo-z in hereditary angioedema (HAE), published in the New England Journal of Medicine. The company anticipates FDA Biologics L... -
XellSmart Secures FDA Fast Track Designation for Off-the-Shelf iPSC-Derived Cell Therapy XS411 for Parkinson’s Disease
BioSpace (XellSmart) USA Overview XellSmart announced that its allogeneic, off-the-shelf iPSC-derived cell therapy candidate, XS411, for Parkinson's disease has received Fast Track Designation (FTD) from the U.S. FDA. XS411 aims to repla... -
Washington University-Developed CAR-T Therapy for T-Cell Leukemia and Lymphoma Receives FDA Breakthrough Therapy Designation: Off-the-Shelf Approach Improves Access
Washington University School of Medicine in St. Louis USA Overview A cell-based immunotherapy developed by Washington University School of Medicine in St. Louis, designed to treat rare and aggressive T-cell acute lymphoblastic leukemia a... -
FDA Grants Four Regenerative Medicine Advanced Therapy (RMAT) Designations in July: Advancements in Musculoskeletal, Ophthalmic, Oncology, and Neurological Fields
Pharmacally USA Overview In July 2026, the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designations to four distinct investigational drugs, spanning diverse regenerative medicine modalities including cell therapies, ge... -
FDA Regenerative Medicine Approvals Accelerate, Outpacing Previous Years with Record Potential for 2026
PharmaLive USA Overview FDA approvals for regenerative medicine products are accelerating significantly, with a record eight approvals in 2024. Approvals between 2023 and 2025 more than doubled the total from 2016-2022. As of July 2026, ...
