Health AffairsOpinion

The FDA Removed REMS For CAR-T Cell Therapy—Now Community Providers Can Expand Access

Consider the case of patient WB, a 79-year-old male with recurrent diffuse large B cell lymphoma. He was referred for ...
Fierce Biotech

As CAR-T cell therapy gains ground on solid tumors, regulatory red tape hinders progress

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 ...
Yahoo

FDA increases manufacturing flexibility for cell and gene therapies

FDA commissioner Marty Makary said eased manufacturing requirements for certain cell and gene therapies were “common-sense reforms” to “foster innovation”. Photo by Andrew Harnik/ Getty Images News ...
MarketWatch

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

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 ...
The Pharma Letter

FDA resumes review of Capricor’s cell therapy deramiocel

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 ...
FiercePharma

Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst

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 ...
Fierce Biotech

FDA illuminates new approval pathway for bespoke gene editing therapies

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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
Axios on MSN

FDA slammed over rare disease drug decisions. Here's why

The Food and Drug Administration's rejection of several new drugs for rare diseases has alarmed patient advocates and ...
Yahoo

FDA increases manufacturing flexibility for cell and gene therapies

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary said eased manufacturing requirements for certain cell and gene therapies were “common-sense reforms ...