Tag: Food & Drug Administration
Most Safety Signals Reported to FDA Lead to Regulatory Action
Regulatory actions by the FDA were corroborated by at least one relevant published research study for 17 of 57 resolved safety signals
FDA Admits Flaws in Response to Infant Formula Shortage
Problems highlighted in report include outdated data-sharing systems, below-normal staffing and training for food inspectors
In Rare Move, FDA Panel Gives Support to Controversial ALS Drug in Second Review
Medication combines a dietary supplement used in traditional Chinese medicine with an existing prescription drug for liver disorders
FDA Approves SPEVIGO for Generalized Pustular Psoriasis Flares
The monoclonal antibody infusion is approved for use in adults
FDA Approves First Treatment for Acid Sphingomyelinase Deficiency
The enzyme replacement therapy is administered through an intravenous infusion and approved for both adult and pediatric patients
FDA Warns of Dangers From Skin-Lightening Creams
Potentially harmful ingredients are hydroquinone or mercury, according to the agency
FDA Approves Omicron-Specific Booster Shots From Pfizer, Moderna
Vaccine advisory panel for the CDC set to meet Thursday and Friday to discuss who should get the updated boosters
FDA Approves Imbruvica for Pediatric Chronic Graft Versus Host Disease
Approval is for chronic disease after failure of one or more lines of systemic therapy
FDA Approves First Cell-Based Gene Therapy for Beta-Thalassemia
The single-dose treatment is approved for transfusion-dependent adults and children
Tabrecta Gains Full FDA Approval for Non-Small Cell Lung Cancer
Drug approved for non-small cell lung cancer with mutation leading to MET exon 14 skipping
