News about "Cell and Gene Therapy"

Centre Revises Drugs Rules for Cell and Gene Therapies

Centre Revises Drugs Rules for Cell and Gene Therapies

The Centre has amended the Drugs Rules, 1945 to bring advanced cell and gene therapies under the Centrally License Approving Authority (CLAA), to include cell and stem cell-derived products, gene therapeutics and xenografts.

Cell And Gene Therapy | 03/07/2026 | By News Bureau

US FDA Releases Draft Guidance to Accelerate Cell and Gene Therapy Development

US FDA Releases Draft Guidance to Accelerate Cell and Gene Therapy Development

The US FDA has issued draft guidance aimed at accelerating the development of cell and gene therapies by enabling sponsors to leverage existing scientific evidence, reduce redundant testing for treatments targeting rare and life-threatening diseases.

Cell And Gene Therapy | 04/06/2026 | By News Bureau

Andelyn Biosciences and ENCell Forge Global Manufacturing Alliance

Andelyn Biosciences and ENCell Forge Global Manufacturing Alliance

Andelyn Biosciences and ENCell partner to build a cross-continental manufacturing network, enabling faster development and global delivery of advanced gene therapies.

Cell And Gene Therapy | 23/04/2026 | By News Bureau

Lonza Expands TheraPEAK Product Portfolio, Launches AmpliCell Cytokines and TheraPEAK 293-GT Medium

Lonza Expands TheraPEAK Product Portfolio, Launches AmpliCell Cytokines and TheraPEAK 293-GT Medium

Switzerland-based Lonza has expanded its GMP solutions for cell and gene therapy with the launch of TheraPEAK AmpliCell Cytokines and TheraPEAK 293-GT Medium.

Cell And Gene Therapy | 07/10/2025 | By Dineshwori 266

ClearPoint Neuro Develops Robotic Neuro-Navigation System to Enhance Cranial Surgery Procedures

ClearPoint Neuro Develops Robotic Neuro-Navigation System to Enhance Cranial Surgery Procedures

ClearPoint Neuro Robotic Neuro-Navigation System will enable the company’s Navigation software to operate the KUKA LBR Med Robotic Arm to support all minimally invasive cranial surgical procedures, including cell and gene therapy infusions, laser catheter placement, biopsy workflows and deep brain stimulation and stereotactic EEG lead placements.

Cell And Gene Therapy | 04/10/2025 | By Dineshwori 576

CDSCO Mandates Online Submission of CGTP Clinical Trial Applications via SUGAM Portal

CDSCO Mandates Online Submission of CGTP Clinical Trial Applications via SUGAM Portal

For now on, offline submissions of clinical trial applications for Cell and Gene Therapy Products (CGTPs) will not be accepted by the CDSCO.

Cell And Gene Therapy | 11/07/2025 | By Dineshwori 417

Miltenyi Biotec India, BIRAC Partner to Advance India's Cell and Gene Therapy Ecosystem

Miltenyi Biotec India, BIRAC Partner to Advance India's Cell and Gene Therapy Ecosystem

The partnership will focus on building local scientific capabilities, CAR-T clinical trials, addressing unmet medical needs and enhancing access through PoC manufacturing centres to strengthen India’s CGT capabilities.

Cell And Gene Therapy | 19/06/2025 | By Abha 362

CSafe Global appoints Amy DuRoss as President, Cell and Gene Therapies

CSafe Global appoints Amy DuRoss as President, Cell and Gene Therapies

Continues investment in cell and gene therapy solutions

Cell And Gene Therapy | 26/07/2022 | By Sudeep Soparkar 376


 

 

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