RMAT– tag –
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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 Bestows RMAT Status on iPSC-Derived Cell Therapy for Intractable Disease, Poised to Accelerate Clinical Development
Company Announcement / Specialized Media USA Overview A regenerative medicine firm has announced its iPSC-derived cell therapy program for an intractable disease has received Regenerative Medicine Advanced Therapy (RMAT) designation from... -
FDA Details Regenerative Medicine Advanced Therapy (RMAT) Designation Framework, Offering Fast Track and Breakthrough Therapy Benefits
Global MedTech Expert USA Overview Global MedTech Expert details the FDA's regulatory framework for 351/361 HCT/P classification and Regenerative Medicine Advanced Therapy (RMAT) designation. RMAT offers significant benefits, including F... -
Allogene’s Off-the-Shelf CAR T Cema-Cel Secures FDA RMAT and Fast Track for High-Risk LBCL First-Line Consolidation
OncLive USA Overview Allogene Therapeutics' off-the-shelf anti-CD19 CAR T-cell therapy, cemacabtagene ansegedleucel (cema-cel), received FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for first-line consoli... -
FDA Regenerative Medicine Approvals Accelerate: Record 8 Approvals in 2024, RMAT Designations Signal Continued Momentum
Pharmaceutical Technology USA Overview U.S. FDA approvals for regenerative medicine products have accelerated significantly, reaching a record eight approvals in 2024. The surge in Regenerative Medicine Advanced Therapy (RMAT) designatio... -
Allogene’s Off-the-Shelf CAR T, Cema-Cel, Earns FDA RMAT and Fast Track for High-Risk LBCL First-Line Consolidation
Allogene Therapeutics, Inc. USA Overview Allogene Therapeutics has secured FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for its investigational allogeneic CAR T-cell therapy, cemacabtagene ansegedleucel (... -
FDA Clarifies Regenerative Medicine Regulations: Strategic Use of RMAT Designation and HCT/P Classification to Accelerate Development
Global MedTech Expert USA Overview The U.S. FDA has detailed its Regenerative Medicine Advanced Therapy (RMAT) designation, offering a fast-track development framework for cell and gene therapies targeting serious or life-threatening dis... -
FDA Regenerative Medicine Advanced Therapy (RMAT) Designations Hit Record High of 48 in 2025, Accounting for 48% of All Designations in Past Two Years
PharmaLive USA Overview According to a GlobalData report, the number of Regenerative Medicine Advanced Therapy (RMAT) designations granted by the FDA reached a record-breaking 48 in 2025, with designations in 2024 and 2025 collectively a... -
U.S. FDA RMAT Designations Surge to 165 Total, with Rocket Pharmaceuticals (5) and CRISPR Therapeutics (4) Leading the Way
BioInformant USA Overview As of July 15, 2026, the cumulative number of Regenerative Medicine Advanced Therapy (RMAT) designations publicly announced by the U.S. FDA has reached 165. Rocket Pharmaceuticals and CRISPR Therapeutics are not... -
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...
