Sens. Warren, Wyden, and Booker ask FDA for information on the efficacy of pulse oximeters when used with patients with darker skin.
CDRH biomedical engineer Devashish Shrivistava analyzes on a Webinar a recent FDA enforcement guidance for bioburden reduction systems using dry heat ...
FDA authorizes additional Phase 1 studies of ERX Pharmaceuticals ERX1000 to treat obesity.
Genmab and Seagen submit a BLA seeking accelerated approval for tisotumab vedotin, indicated for treating patients with recurrent or metastatic cervic...
FDA warns Clarke Pharmaceuticals it is marketing unapproved and misbranded new drugs.
FDA approves Allergans Botox for treating detrusor (bladder muscle) overactivity associated with a neurologic condition in certain pediatric patients ...
A group of Democrats on the House Oversight Committee urge FDA to remove the in-person dispensing requirement for medical abortion drug mifepristone.
FDA clears an Ava 510(k) for its wearable Fertility Tracker to aid women in ovulation prediction and facilitating conception.