Silver Spring, MD, June 02, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration (FDA) today issued draft guidance ...

FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...

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

A team of researchers led by Luigi Naldini at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget) has developed a ...

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

The Food and Drug Administration on Tuesday will issue draft guidance for how companies developing cell and gene therapies ...

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 ...

More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...

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 ...

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.

The US Food and Drug Administration has approved the first-ever gene therapy specifically targeting genetic hearing loss—a ...