Tag: Food & Drug Administration
FDA OKs Marketing of New Device to Reduce Snoring, Mild OSA
The removable eXciteOSA device, to be used when a patient is awake, delivers neuromuscular stimulation to the tongue
J&J Submits EUA Request for COVID-19 Vaccine
FDA committee will hold public meeting to discuss the EUA request on Feb. 26
FDA: All Alcohol-Based Hand Sanitizers From Mexico on ‘Import Alert’
Large number of hand sanitizers from Mexico have tested positive for methanol contamination
FDA Approves First Monthly Injectable Regimen for HIV
Trials show virologic suppression in comparable numbers of patients receiving monthly injection with Cabenuva, daily current antiretroviral regimen
Hahn Resigns as Head of FDA, Dr. Janet Woodcock New Interim Chief
A permanent FDA commissioner has not yet been nominated, but Woodcock is under consideration
Top FDA Officials Say Two Full Doses of COVID-19 Vaccines a Must
Agency says it is understandable that people may want to stretch the vaccine supply, but it is not safe to do so
FDA Authorizes Marketing of EndoRotor System
Device provides minimally invasive way to resect and remove necrotic tissue in patients with walled-off pancreatic necrosis
FDA Approves Implant System for Transfemoral Amputations
The OPRA Implant System is surgically anchored and integrated into a patient's remaining thigh bone
Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations
Current approval of the once-daily tablet indicated for patients who have undergone complete tumor removal
FDA Issues EUA for Moderna COVID-19 Vaccine
On Sunday, ACIP voted to recommend frontline workers and those ages 75 years and older be included in next phase of vaccine distribution
