Tag: Food & Drug Administration
Advisory Committee Votes to Recommend EUA for Moderna Vaccine
Could become the second COVID-19 vaccine in a week to receive emergency use authorization
FDA Authorizes Marketing of ACL Implant
The BEAR Implant offers alternative to ACL reconstruction with allograft, autograft, or suture-only repair
Pfizer-BioNTech Vaccine Receives Emergency Use Authorization
CDC director says vaccine distribution could begin as early as today
FDA Advisory Committee OKs Pfizer-BioNTech COVID-19 Vaccine
Committee recommends emergency use authorization of the vaccine; vaccine to be distributed within 24 hours of EUA
Masks Containing Metal Could Cause Burns During MRI, FDA Warns
Metal parts include bendable nose clips, staples on the headband, nanoparticles, or antimicrobial coating
FDA Review Finds Pfizer COVID-19 Vaccine Effective After First Dose
Vaccine is expected to receive emergency use authorization later this week
FDA Approves Drug for PET Imaging of Prostate Cancer
Approval of Gallium 68 PSMA-11 provides new imaging approach to detect prostate cancer metastasis or recurrence
Xofluza Approved for Postexposure Prevention of Flu
Influenza infection and symptoms occurred in 1 and 13 percent of those receiving Xofluza and placebo, respectively
First Drug Approved to Treat Rare Metabolic Disorder
Oxlumo granted approval to treat primary hyperoxaluria type 1
FDA Authorizes Use of Monoclonal Antibody Treatment for COVID-19
IV infusion of casirivimab and imdevimab authorized for treatment of mild-to-moderate COVID-19
