Regulatory

Navigating cell therapy's maze of risks
Wednesday, September 03, 2025
Biopharma companies advancing cell therapies must confront a range of key considerations and risks. A strategic, collaborative approach can accelerate development and ... read more
Navigating the realities of CAR-T cell oncology trials
Wednesday, August 20, 2025
Given the undeniably novel aspect of this new paradigm, however, conducting CAR-T clinical trials presents a unique set of obstacles for sponsors, sites and regulators to... read more
Cellular rebirth
Wednesday, August 06, 2025
After decades of research that hadn’t translated into efficacy in patients and a proliferation of unsubstantiated stem cell science, MSCs seemed stuck in therapeutic ... read more
MSCs rising
Wednesday, July 30, 2025
With MSCs back in the spotlight and a pipeline of mid- and late-stage candidates pushing toward regulatory submission, what looms now is not a question of whether MSCs ... read more
Navigating nuanced CGT clinical trial logistics
Wednesday, June 11, 2025
Advances in interactive response technology platforms for drug supply can be highly beneficial when thoughtfully designed to address the unique challenges of CGT trials. ... read more
FDA approvals for cell and gene therapies stay on track
Monday, November 25, 2024
The industry stays on track with FDA approvals for cell and gene therapies read more
Navigating the complexities of analytical validation for advanced therapies
Wednesday, November 20, 2024
Generating an analytical strategic plan and developing methods appropriately during process development will help ensure quality, safety and efficacy read more
Maintaining contamination control in advanced therapy manufacturing
Wednesday, November 06, 2024
Facilities that make cell and gene therapies require cleaning and disinfection strategies not found at other drug manufacturing sites read more

CBER head Vinay Prasad resigns amid controversy
Prasad, tangled in a public dispute with Sarepta, has left the FDA after less than three months as director of CBER.
Wednesday, July 30, 2025
FDA to halt trials that send Americans’ cells to labs in “hostile” countries
The agency will immediately review clinical trials that involve sending Americans' living cells to China and other “hostile” countries for genetic engineering.
Friday, June 20, 2025
Sarepta wins first FDA platform technology designation for gene therapy
Once granted, the designation enables sponsors to leverage prior data from the platform to support INDs, NDAs or BLAs.
Thursday, June 05, 2025
FDA puts Rocket Danon disease trial on hold following patient death
The FDA hold was placed on the trial on Friday May 23, and unfortunately the patient has since passed away after an acute systemic infection.
Tuesday, May 27, 2025
FDA approves Abeona gene therapy for rare skin disease
Zevaskyn is the only FDA-approved product to treat recessive dystrophic epidermolysis bullosa wounds with a single application.
Tuesday, April 29, 2025