Tag: Food & Drug Administration
FDA Approves Dengue Vaccine for Endemic Regions
Vaccine indicated for individuals aged 9 to 16 who have previously had laboratory-confirmed dengue disease
FDA: Breast Implants Linked to Cancer Can Still Be Sold in U.S.
Agency considering new patient warnings and checklists for the implants
FDA Approves Mavyret for Children, Adolescents With Hep C
Drug approved for treatment of all six genotypes of hepatitis C virus in children ages 12 to 17
FDA Puts Tough Warning Label on Ambien, Lunesta, Other Sleep Aids
Move spurred by 66 cases of 'complex sleep behaviors' after taking the insomnia medications
FDA Approves Device That Allows for Reassessment of Lung Transplant Suitability
With Xvivo Perfusion System, surgeons can reassess lungs originally considered unsuitable for transplant
FDA Approves First Treatment for Pediatric Lupus
Approval based on study showing children who received Benlysta plus standard therapy had lower risk for flare
FDA Announces New Steps to Reduce Risks Tied to Surgical Staplers
Agency proposing higher classification of surgical staplers that will require premarket notification clearance
FDA Approves Pembrolizumab Plus Axitinib for Advanced RCC
Drug combination approved for advanced renal cell carcinoma based on findings from KEYNOTE-426
FDA Approves Marketing of First Device to Treat ADHD
Monarch eTNS System approved for children 7 to 12 years old not taking prescription ADHD medication
FDA Approves First Generic Nasal Spray Against Opioid Overdose
Product is also first generic naloxone nasal spray approved for use by people without medical training
