The Food and Drug administration is a US federal agency responsible for protecting public health. It is the body responsible for regulation and approval of drugs and other pharmaceutical products such as vaccines within the USA.
A Phase 2/3 trial assessing a gene therapy for X-linked retinitis pigmentosa (XLRP) shows significant improvements in low-light vision...
A CRISPR-based therapy continues to reduce harmful cholesterol levels in patients after a one-year follow-up in a Phase 1 clinical trial...
New evidence on the risks of gestational surrogacy should strengthen the case for better safeguards, writes Dr Carole Gilling-Smith...
The US Food and Drug Administration (FDA) has put a clinical hold on an experimental gene therapy for Hunter syndrome due to nodules being discovered in the spine of five patients who previously received treatment...
The US Food and Drug Administration is allowing biotech company uniQure to reapply for the licensing of a gene therapy that could slow the progression of Huntington's disease...
A new experimental gene therapy has shown early success in treating a rare genetic epilepsy syndrome...
A novel topical gene therapy for the treatment of a rare genetic skin disorder has been approved by the Medicines and Healthcare products Regulatory Agency...
Adeno-associated virus gene therapy vector DNA has been found integrated within tumour tissue in a patient with Hurler syndrome who had been treated years earlier...
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