Federal Register Notice: FDA announces a 4/12 public workshop on new developments and scientific issues related to antibody mediated rejection in kidn...
Federal Register Notice: FDA co-sponsors with Xavier University a public conference entitled FDA/Xavier University Medical Device Conference.
Federal Register Notice: FDA determines that Pernix Therapeutics antibiotic Cedax (ceftibuten dihydrate) for oral suspension, 90mg/5mL and 180mg/5mL, ...
Medtronic issues a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010 due to reports that the vent...
Faced with harsh criticism from Democrats about his ties to regulated industry, FDA commissioner nominee Scott Gottlieb tells members of the Senate He...
Sens. Markey and Brown say they oppose the nomination of Scott Gottlieb to be FDA commissioner because he will not effectively use FDA to battle the n...
FDA clears a VivaLnk 510(k) for the Fever Scout, a soft, wearable thermometer that continuously measures a persons temperature.
Amgen files a supplemental BLA for Xgeva (denosumab) to expand its use for preventing skeletal-related events in solid tumors to include patients with...