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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Problems highlighted in report include outdated data-sharing systems, below-normal staffing and training for food inspectors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

FDA Warns Amazon, Other Vendors About Sale of Skin Tag Removal Products

No over-the-counter medications have FDA approval for the removal of moles and skin tags