Tag: Food & Drug Administration
FDA Approves Venetoclax for Chronic, Small Lymphocytic Leukemia
In randomized trial, drug demonstrated statistically significant improvement in progression-free survival
FDA Approves Ruzurgi for Children With Rare Autoimmune Disorder
Ruzurgi previously approved for treatment in adults with Lambert-Eaton myasthenic syndrome
FDA Approves Treatments for Heart Failure Caused by Rare Disease
Capsules approved to treat cardiomyopathy caused by transthyretin mediated amyloidosis
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
