FDA Commissioner Califf acknowledges that regulatory pathways for gene therapies are still being developed and that many factors outside of the modality impact agency requirements as he emphasized the need for long-term follow up due to the unknowns of gene modification.
Long periods of follow-up may be necessary for gene therapies, particularly if and when the US Food and Drug Administration is willing to grant a company an accelerated approval for such a treatment, FDA Commissioner Robert Califf said.
At the J.P. Morgan Healthcare Conference 10 January, Califf was asked for his assessment of what circumstances he envisions gene...
Despite recent political turmoil, outside investor and corporate interest in South Korean biopharma innovation appears robust or even increasing.
Agnès Arbat, CEO of Oxolife and winner of the EU Women Innovators Prize, joins In Vivo to discuss OXO-001, a novel non-hormonal treatment aimed at improving embryo implantation in IVF. She shares insights from her biotech journey and the future of fertility innovation.
