TodayNewsroomsU.S. Food and Drug Administration
Newsroom
9 stories on Tazzora credit U.S. Food and Drug Administration. The reporting is theirs, and each summary links to the original article.
Newest first. The original article stays linked on each story.
Health & TechAwiqli, insulin icodec, is now cleared for patients 10 and older with type 2 diabetes, along with diet and exercise. It replaces a daily basal shot with one a week.
Verified · U.S. Food and Drug Administration
Health & TechIn two placebo-controlled trials of Hibsago (bepirovirsen), 24 percent of patients qualified to stop antivirals, and 19 percent still had the virus controlled 24 weeks after ending all treatment. The drug carries a boxed safety warning.
Verified · U.S. Food and Drug Administration
Health & TechJemperli, or dostarlimab, received accelerated approval for untreated stage II or III dMMR or MSI-H rectal cancer. In a 154-patient trial, nearly three-fourths needed no chemo, radiation, or surgery after more than two years. That subtype is about 3 percent of rectal cancers.
Verified · U.S. Food and Drug Administration
Health & TechThe FDA expanded Anktiva, given with BCG, to adults with BCG-unresponsive high-grade papillary-only bladder cancer. A related trial, not this exact group, saw a 62 percent complete response.
Verified · U.S. Food and Drug Administration
Health & TechHovilpri (pritelivir) is for immunocompromised adults whose lesions did not respond to acyclovir, valacyclovir, or famciclovir. The trial was open-label, and herpes still has no cure.
Verified · U.S. Food and Drug Administration
Health & TechIn a 712-patient trial, adding atezolizumab to chemotherapy after surgery halved the risk of the cancer returning or of death. Median disease-free survival was not reached, and overall survival was not the result reported.
Verified · U.S. Food and Drug Administration
Health & TechIn a 654-person maintenance trial, median progression-free survival was 24.9 months with tucatinib and 16.3 months with placebo. Overall survival is not known yet.
Verified · U.S. Food and Drug Administration
Health & TechIn a 282-person trial, the cancer took longer to worsen than with a common chemoimmunotherapy. Survival is not proven, and the approval excludes a 17p deletion.
Verified · U.S. Food and Drug Administration
Health & TechIn a study of 62 children, the Autus valve met the FDA's six-month bar. Only two have been expanded so far, and longer follow-up is still underway.
Verified · U.S. Food and Drug Administration