11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, but there was a similar rate of submissions across regulators for oncology drugs and those deemed by authorities of having moderate-to-high therapeutic value, according to recent research published in Health Affairs.

While the US FDA received a majority of new drug submissions, the agency also received a higher proportion of non-cancer, non-orphan drugs, drugs not on expedited approval pathways, and drugs considered by regulators as having a low therapeutic value when compared to other international regulators, Irene Papanicolas, a health economist and health services researcher at Brown University in Providence, Rhode Island, and colleagues said.

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