Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...

Otarmeni, a surgically-delivered drug developed by Regeneron, recently received accelerated FDA approval to treat a rare, ...

Stem cell transplantation is the most cost-effective option for long-term care of sickle cell disease in adults when compared ...

UCSD study says the therapy increased expression of a neuroprotective protein to help preserve brain functions, despite the ...

June 2 (Reuters) - The U.S. Food and Drug Administration on Tuesday proposed allowing makers of cell and gene therapies ...

The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...

In the latest part of its plan to cut barriers to cell and gene therapy (CGT) development, the FDA has published draft ...

In a worldwide first, a one-and-done gene therapy has been approved to treat a form of hereditary deafness. Many of the children treated can hear normally and speak.

Cell and gene therapies, or CGT, have come a long way since they were first introduced. In the last few decades, both cell therapy—the transplantation of living cells—and gene therapy—the use of ...

The FDA’s press release noted that the guidance supports development of an array of cell and gene therapy products, including ...