Consider the case of patient WB, a 79-year-old male with recurrent diffuse large B cell lymphoma. He was referred for ...
A new, highly sensitive cell therapy was able to wipe out three different kinds of solid tumors in mice, an important advance in an area where CAR-T cells have long struggled. But significant ...
On January 11, 2026, the FDA issued two news releases putting forward reforms to the chemistry, manufacturing, and control requirements for cell and gene therapy products, one titled FDA Increases ...
The MarketWatch News Department was not involved in the creation of this content. White Oak, Md., Jan. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced it is sharing ...
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 ...
US biotech Capricor Therapeutics (Nasdaq: CAPR) says the US Food and Drug Administration has resumed review of its biologics license application for deramiocel to treat cardiomyopathy linked to ...
The sudden departure of Vinay Prasad, M.D., from the FDA this week again threw the cell and gene therapy field into uncertainty. But this time, the unknown is hitting the industry in a different way ...
The US Food and Drug Administration (FDA) has created a new pathway to bring personalised therapies to market that can bypass certain requirements, using the success of Baby KJ’s treatment as a ...
After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
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