In The News

September 21, 2021
In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a…
September 16, 2021
Eliminating inequities in health care is an important priority. One persistent inequity involves the lack of data to guide cancer care for older adults. Although clinical trials provide the strongest…
August 27, 2021
While groups expressed overwhelming support for the US Food and Drug Administration’s (FDA’s) draft guidance expanding eligibility criteria for investigational oncology trials, some comments…
August 18, 2021
Circulating tumor DNA, tumor mutational burden, and homologous recombination deficiency are 3 emerging biomarkers for tailoring therapy need further clinical and technical clarity to support robust…
August 10, 2021
WASHINGTON — For most of its history, the Food and Drug Administration’s shortcut pathway for approving certain medicines was hardly contentious among anyone but the most diehard agency nerds; for…
August 2, 2021
President Biden’s proposed Advanced Research Projects Agency for Health (ARPA-H) might be able to provide the leadership necessary to cut across barriers between industry and government and within…
August 2, 2021
In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, the agency’s leading cancer expert lashed…
July 30, 2021
During a listening session convened by the Friends of Cancer Research (FOCR) with Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on their nascent Cures 2.0 package, Richard Pazdur, director of the…
July 29, 2021
Accelerated approval is “under attack,” by critics who are “one-sided” and not taking a comprehensive look at the program, said Rick Pazdur, the director of the US Food and Drug Administration’s…
July 29, 2021
The FDA's cancer chief pushed back against criticisms over the agency's expedited approval mechanisms, calling them one-sided arguments that fail to recognize the benefits of making potentially…