The latest breakthrough therapy designation (BTD) awards from FDA illustrate the expedited review program's appeal for sponsors who are entering Phase III in areas where there is little relevant precedent to guide trial design.
Increased communication with US regulators will help advanceSynthetic Biologics Inc.'s microbiome therapeutic, Proteon Therapeutics Inc.'s recombinant vasodilator, and River Vision Development Corp.'s (now Horizon Pharma PLC's) antibody for a rare inflammatory eye disorder
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