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AstraZeneca to build cell therapy hub, innovation center in Shanghai
The drugmaker will establish a commercial cell therapy manufacturing and supply base and innovation center in Shanghai. read more
Saturday, March 21, 2026
Sarepta begins enrolling patients in Elevidys immunosuppressive regimen trial
The cohort will assess a prophylactic sirolimus treatment as part of an enhanced safety protocol during treatment with Elevidys. read more
Wednesday, March 18, 2026
Ultragenyx gets phase 3 win for urea cycle disorder gene therapy
OTC deficiency is caused by a genetic defect in a liver enzyme responsible for detoxification of ammonia. read more
Friday, March 13, 2026
FDA clears China-based Unixell’s iPSC-derived cell therapy for trials
The IND marks the first time the FDA has allowed this type of cell therapy for epilepsy to be tested in humans. read more
Friday, March 13, 2026
BioCurie gets $9.3M ARPA-H award to build AI platform for scalable gene therapy
Under the ARPA-H award, BioCurie will design, build and validate an AI-powered digital platform that replaces trial-and-error process development. read more
Thursday, March 12, 2026
Sangamo advances rolling submission of BLA for Fabry disease gene therapy
Sangamo believes that the totality of data from the registrational STAAR study demonstrates the potential of ST-920 as a one-time, well-tolerated and durable gene therapy treatment option. read more
Wednesday, March 11, 2026
FDA lifts CRL for Capricor Duchenne cell therapy
If approved, deramiocel has the potential to become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophy. read more
Wednesday, March 11, 2026
Prasad to depart CBER, again
Dr. Vinay Prasad will once again leave his position as head of CBER, FDA Commissioner Marty Makary announced to agency staff in an email late Friday. read more
Monday, March 09, 2026
NexCure launches with $19M Series A to deliver outpatient CAR-T
The company’s proprietary platform standardizes protocols, automates care coordination, and reduces operational variability. read more
Thursday, March 05, 2026
Prime to seek FDA approval for gene-editing treatment using two-patient trial
Prime Medicine will seek accelerated FDA approval of its ex vivo prime edited autologous hematopoietic stem cell product. read more
Thursday, March 05, 2026
Pierre Fabre requests FDA Type A meeting for twice-rejected T-cell therapy
The urgent meeting is to discuss the twice-rejected tabelecleucel for relapsed/refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease. read more
Wednesday, March 04, 2026
XellSmart secures fourth dual U.S/China regulatory nod for iPSC-derived cell therapy trials
The company has clearance for phase 1/2 registrational clinical trial entry with its allogeneic, iPSC-derived spinal neural progenitor cell therapy. read more
Wednesday, March 04, 2026

Cell and gene therapy news

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AstraZeneca to build cell therapy hub, innovation center in Shanghai

Sarepta begins enrolling patients in Elevidys immunosuppressive regimen trial

Ultragenyx gets phase 3 win for urea cycle disorder gene therapy

FDA clears China-based Unixell’s iPSC-derived cell therapy for trials

BioCurie gets $9.3M ARPA-H award to build AI platform for scalable gene therapy

Sangamo advances rolling submission of BLA for Fabry disease gene therapy

FDA lifts CRL for Capricor Duchenne cell therapy

Prasad to depart CBER, again

NexCure launches with $19M Series A to deliver outpatient CAR-T

Prime to seek FDA approval for gene-editing treatment using two-patient trial

Pierre Fabre requests FDA Type A meeting for twice-rejected T-cell therapy

XellSmart secures fourth dual U.S/China regulatory nod for iPSC-derived cell therapy trials

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