Tag: Food & Drug Administration
Opdivo Plus Chemotherapy Approved for Treatment of Gastric Cancer
FDA granted Opdivo first approval of immunotherapy for first-line treatment of advanced or metastatic gastric cancer
FDA to Set Limits on Toxic Elements in Baby Food
Agency said it will assess the science, set maximum acceptable levels, and monitor baby food makers' compliance
FDA: ‘Real Water’ Alkaline Water May Be Linked to Hepatitis Outbreak
FDA is in beginning stages of investigation; there may be more products connected to hepatitis outbreak
FDA Warns Consumers to Not Use Ivermectin for COVID-19
Agency has received reports of patients requiring medical support after self-medicating with ivermectin for use in horses
AstraZeneca to Seek FDA Approval of COVID-19 Vaccine Within Weeks
If the two-dose vaccine is approved, it would be the fourth COVID-19 vaccine available in the United States
Robotically Assisted Surgical Device Authorized for Transvaginal Hysterectomy
Hominis Surgical System granted marketing authorization approval for use in benign hysterectomy with salpingo-oophorectomy
J&J COVID-19 Vaccine Granted Emergency Use Authorization
The single-dose Ad26 vaccine is now the third COVID-19 vaccine to be granted an EUA
FDA Warns Not to Rely on Pulse Oximetry for Diagnosis, Treatment Decisions
Safety communication follows NEJM study showing risk for inaccuracy with use of pulse oximeters in those with dark skin pigmentation
FDA Approves Therapy to Protect Bone Marrow Cells From Effects of Chemotherapy
Cosela reduces the frequency of bone marrow suppression caused by chemotherapy for extensive-stage small cell lung cancer
Combination Monoclonal Antibody Treatment Authorized for COVID-19
EUA issued for combination of bamlanivimab and etesevimab in patients with mild-to-moderate COVID-19 at high risk for disease progression
