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WASHINGTON, D.C. — The U.S. Food and Drug Administration has released draft guidance that could shorten development timelines for gene therapies by allowing drugmakers to make greater use of existing …
FDA Issues Gene Therapy Guidance Aimed at Faster Reviews Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has granted accelerated approval to Forzinity (elamipretide) injection, the first treatment for Barth syndrome, a rare and life-threatening mitochondrial disease that …
FDA Approves First Drug for Rare, Fatal Barth Syndrome Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has initiated an immediate review of clinical trials involving the international transfer of Americans’ living cells for genetic engineering and subsequent …
FDA Investigates Clinical Trials Sending U.S. DNA Overseas Read More