FDA/CDC
FDA/CDC
FDA limits use of J&J COVID vaccine over blood clot risk
“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global...
FDA/CDC
FDA approves two vonoprazan therapies for H. pylori eradication
“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment...
FDA/CDC
FDA clears diagnostic test for early Alzheimer’s
“There is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status,...
News
CDC reports first human case of H5 bird flu in the U.S.
FDA/CDC
FDA: Switch to disposable duodenoscope models
The agency has updated its April 2020 guidance after postmarket surveillance found partially or fully disposable models can cut the risk of...
FDA/CDC
FDA okays semaglutide higher dose, 2 mg/week, for type 2 diabetes
The 2-mg weekly dose is associated with greater A1c reduction and more weight loss.
FDA/CDC
FDA approves HIV injectable Cabenuva initiation without oral lead-in
Cabenuva injections may be given as few as six times a year to manage HIV.
FDA/CDC
Congress opens investigation into FDA’s handling of a problematic heart device
The FDA took no decisive action even as safety problems with the LVAD persisted.
Latest News
FDA approves new immunotherapy combo for metastatic melanoma
Approval is based on findings that show median progression-free survival of 10.1 months.
FDA/CDC
FDA approves upadacitinib for ulcerative colitis
The JAK inhibitor has been shown to rapidly control symptoms in adults with moderate to severe active ulcerative colitis.