Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond.
The study, published in JAMA Internal Medicine, found that 19 of 93 cancer drugs that won accelerated approval over 25 years improved overall survival, while others only showed improvements on other surrogate endpoints.
Zelis highlights how employers, payers, and consumers are integrating digital tools to manage healthcare costs.
Drugmaker applies for selinexor in penta-refractory multiple myeloma, in which bluebird's bb2121 has also shown efficacy.