FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.

Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing platform. The FDA has granted the company’s IRO platform an Advanced Manufacturing ...

In the complex process of producing a gene therapy, bioprocessors depend on assays to monitor the attributes of the product at various stages. Scientists at Thermo Fisher Scientific focus on ...

With the FDA expecting to approve 10–20 Cell and Gene Therapies (CGTs) annually by 2025, it is evident that the field will continue to hold immense commercial and medical opportunities. To harness ...

Raw materials play a critical role in cell therapy manufacturing. Choosing suboptimal materials at any stage of development ...

The cell and gene therapy sector has never lacked attention, but all too often, the narrative swings from one extreme to ...

"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are common-sense reforms that will address the unique characteristics of cell and ...

Out of the shadows, new CDMO Artis BioSolutions has decloaked on a mission to tackle the tricky production process for advanced therapeutics. Artis officially emerged from stealth on Wednesday, ...

Cell and gene therapy (CGT) has evolved from a niche research pursuit into a central force in biopharmaceutical innovation. By engineering living cells and genetic material to repair or replace faulty ...

VILNIUS, LT / ACCESS Newswire / July 29, 2025 / Diorasis Therapeutics (“DTx”), a preclinical-stage biotechnology company developing gene therapies for ophthalmic diseases, has entered into a strategic ...

Leveraging Northway Biotech’s 20+ years of CDMO expertise, Diorasis Therapeutics is advancing AAV gene therapy for glaucoma treatment VILNIUS, LT / ACCESS Newswire / July 29, 2025 / Diorasis ...