Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...

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

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

When CAR T-therapies first reached the market, they came with warnings and monitoring requirements to protect patients — for good reason. Engineering a patient’s own immune cells into targeted cancer ...

On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...

In a move that could dramatically expand access to a revolutionary new treatment, the Food and Drug Administration (FDA) has eliminated some of the safety restrictions for CAR T-cell therapies. This ...

The FDA eliminated the REMS program and shortened both the post-infusion driving restriction and the required duration of proximity to a healthcare facility. The Food and Drug Administration (FDA) has ...

The U.S. Food and Drug Administration (FDA) approved label updates for Bristol Myers Squibb & Co.’s (NYSE:BMY) CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) for large B cell ...

The U.S. Food and Drug Administration (FDA) recently issued three draft guidances concerning development of cell and gene therapy (CGT) products. The guidances provide advice concerning qualifying ...