FDA

March 25th 2025

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis based on positive findings from multiple Phase III trials.

February 13th 2025

Recent actions by the FDA and NIH in response to the current political climate have left key stakeholders in clinical trials with limited resources to conduct equitable research.

January 8th 2025

Study finds the typical cost of clinical research for developing new drugs is lower than previously estimated, with median costs providing a more accurate reflection than mean costs.

September 20th 2024

Final guidance suggests sponsors select two doses for Phase II trials with additional data requirements.