Abbott issues a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash g...
OncoSec says its Tavo-EP in combination with Mercks Keytruda failed to meet the overall response rate primary endpoint in a Phase 2 trial with some me...
FDA warns Fullerton, CA-based Synovo Production about its manufacturing and distribution of adulterated and misbranded orthopedic medical devices.
Lilly researchers say FDA was consistent in meeting its mid-cycle communication goals under a 2012 program to educate regulatory professionals about t...
FDA approves an emergency use authorization for InflaRxs Gohibic to treat some hospitalized Covid-19 patients.
FDA clears a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray.
FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as...
CBERs Office of Compliance and Biologics Quality sends an untitled letter to Minneapolis Regenerative Medicine over claims made on the firms Web site....
