The first drug to ever slow the progression from pre-diabetes to clinical type 1 diabetes is one step closer to reaching the market. On August 5, the US Food and Drug Administration (FDA) granted breakthrough therapy designation to teplizumab, a CD3-targeted antibody from Provention Bio, to prevent or delay type 1 diabetes onset among children and adults at high risk of developing the disease… Para acessar a publicação na íntegra clique aqui Fonte: Nature Biotechnology | VOL 37 | OCTOBER 2019 | 1099–1109 | www.nature.com/naturebiotechnology …
2019 FDA drug approvals
The FDA’s Center for Drug Evaluation and Research (CDER) approved 48 novel drugs in 2019 (Table 1). Although this approval count falls short of CDER’s record 59 approvals of 2018, it still comes in as the third biggest approval class in the past 25 years (Fig. 1). CDER’s 5-year rolling approval average now stands at 44 new drugs per year, double the nadir of 22 in 2009… Para acessar a publicação na íntegra clique aqui Fonte: 80 | February 2020 | volume 19 www.nature.com/nrd…