FDA– tag –
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Porton Advanced’s UC-MSC Cell Bank for Exosome Manufacturing Receives FDA Drug Master File (DMF) Acceptance
Morningstar USA Overview Porton Advanced, a CDMO, announced that its umbilical cord-derived mesenchymal stem cell (UC-MSC) cell bank for exosome manufacturing has received Drug Master File (DMF) acceptance from the U.S. FDA. This accepta... -
MeiraGTx Secures Up To $400 Million From Oberland Capital to Support Commercialization of Two Gene Therapies
Fierce Biotech USA Overview MeiraGTx has finalized a funding agreement with Oberland Capital totaling up to $400 million. This capital will support the commercialization of the company's two late-stage gene therapy candidates: bota-vec f... -
Emmecell’s Magnetic Human Corneal Endothelial Cell Therapy EO2002 Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
Business Wire USA Overview Emmecell announced that its magnetic human corneal endothelial cell therapy, EO2002, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA. EO2002 is an innovative regenerat... -
Fate Therapeutics Receives FDA IND Approval for CAR-T Therapy FT839 for Autoimmune Diseases, Advancing to Phase 1/2 Clinical Trial
GlobeNewswire USA Overview Fate Therapeutics has received U.S. FDA Investigational New Drug (IND) approval for its CAR-T cell therapy candidate, FT839, targeting autoimmune diseases. The company plans to initiate a Phase 1/2 basket clini... -
Siren Biotechnology Secures $8 Million Non-Dilutive Funding from CIRM to Advance Brain Tumor Gene Therapy SRN-101
Phacilitate USA Overview Siren Biotechnology has been awarded $8 million in non-dilutive funding from the California Institute for Regenerative Medicine (CIRM). This significant capital injection will be used to support the clinical deve... -
FDA Approves Casgevy for Expanded Use in Pediatric Patients Aged 2 and Older with Sickle Cell Disease and Transfusion-Dependent Beta-Thalassemia
Seeking Alpha USA Overview Crispr Therapeutics and Vertex Pharmaceuticals announced that the U.S. FDA has approved an expanded indication for Casgevy (exagamglogene autotemcel) to include pediatric patients aged 2 and older with sickle c... -
FDA Approves Orca Bio’s Tregzi to Reduce GvHD Incidence and Improve Outcomes in Blood Cancer Patients Undergoing Allogeneic HSCT
Precision Oncology News USA Overview The U.S. FDA has approved Orca Bio's precision-engineered donor-derived cell therapy, Tregzi. Tregzi aims to significantly reduce the incidence of graft-versus-host disease (GvHD) while maintaining th... -
Catalent and Nanoscope Expand Supply Partnership for Commercialization of Optogenetic Gene Therapy MCO-010 for Retinal Degenerative Diseases
LucidQuest Ventures USA Overview Catalent and Nanoscope Therapeutics have expanded their partnership to support the late-stage development and commercial supply of MCO-010, an optogenetic gene therapy candidate for retinal degenerative d... -
Overcoming Cell Therapy Manufacturing Bottlenecks: Mandating Closed, Reproducible, and Scalable Production Platforms
Frontiers Switzerland Overview As cell therapy products move towards commercialization, their manufacturing processes pose significant challenges regarding critical quality attributes, patient safety, and commercial viability. Addressing... -
CRISPR Gene Therapies Expand in 2026: EDIT-101 for Retinitis Pigmentosa Gains FDA Accelerated Approval, Following Casgevy for Sickle Cell Disease
Ubie Doctor's Note Japan Overview By 2026, CRISPR-based gene therapies are rapidly expanding, with EDIT-101 for retinitis pigmentosa receiving FDA accelerated approval in late 2025, building on the 2023 approval of Casgevy for sickle cel...
