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Results For "cell-therapy"

91 News Found

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels
Drug Approval | June 28, 2025

FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels

Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access


Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification
News | May 28, 2025

Fluor-built Bayer cell therapy facility in California achieves LEED v4 platinum certification

Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs


Astellas and YASKAWA to establish JV focused on cell therapy manufacturing
News | March 10, 2025

Astellas and YASKAWA to establish JV focused on cell therapy manufacturing

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma
Diagnostic Center | October 09, 2024

Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma

India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma


BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months
Diagnostic Center | September 27, 2024

BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months

At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts


AGC and Medinet sign agreement for cell therapy CDMO business
News | September 12, 2024

AGC and Medinet sign agreement for cell therapy CDMO business

A new initiative to contribute to enhancing drug discovery capabilities in the field of gene and cell therapy in Japan


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile


BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel
Drug Approval | May 31, 2024

BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel

Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s disease


Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA
Diagnostic Center | May 20, 2024

Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA

95.7% of patients responded to Breyanzi in the TRANSCEND FL trial


ImmunoACT announces the approval of India's first CAR-T cell therapy 'NexCAR19'
News | October 16, 2023

ImmunoACT announces the approval of India's first CAR-T cell therapy 'NexCAR19'

NexCAR19 is an indigenously developed CD19 targeted CAR-T cell therapy