Laura DeFrancesco

The controversial approval of an antisense drug for muscular dystrophy dominated news this quarter, with overall approvals down compared with recent years. Two biosimilars made it over the finish line at the US Food and Drug Administration (FDA), and the European Medicines Agency Historic FDA approvals by drug type (EMA) approved a genetically modified allogeneic T-cell therapy for use in bone marrow/stem cell transplants. A slew of breakthrough designations included two gene therapies; December looks to be a busy month at the FDA.
The trend for fewer drug approvals continues in 2016.


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