Food and Drug Administration News

Health Tips

• Health Tip: Use Medical Devices Safely
  
• Health Tip: Protect Your Food From Hurricane Threats
  

FDA Approvals

• FDA Approves IV Artesunate for Severe Malaria
  Drug is first to be approved since discontinuation of quinine in 2019
• VESIcare LS Approved for Neurogenic Detrusor Overactivity
  Oral suspension treatment is the first approved for NDO patients as young as 2 years
• Qinlock Approved as Fourth-Line Treatment for GIST
  Approval based on study showing PFS of 6.3 months with Qinlock versus one month with placebo
• FDA Approves Retevmo for Certain Lung, Thyroid Cancers
  Approval indicated for NSCLC, medullary thyroid cancer, other thyroid cancers with RET gene alteration
• FDA OKs Farxiga for Heart Failure With Reduced Ejection Fraction
  The SGLT2 inhibitor is indicated for reducing the risk for CV death, hospitalization for heart failure
• FDA Approves Trodelvy for Metastatic Triple-Negative Breast Cancer
  Approval indicated for those who have received at least two previous therapies