FDA posts a draft guidance entitled Human User Safety in New and Abbreviated New Animal Drug Applications to inform sponsors of the types of informati...
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...
