Black Box Warning

FDA Imposes Boxed Warning and Restricts Use of Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

3 weeks ago talkbio0Tagged Black Box Warning, ELEVIDYS, gene therapy, Indication restriction, Liver Failure, Acute, Muscular Dystrophy, Duchenne, Post-marketing study, Safety labeling, United States Food and Drug Administration

Elevidys; Sarepta Therapeutics; Duchenne muscular dystrophy; FDA; Boxed warning; Gene therapy; Acute liver failure; Safety labeling; Indication restriction; Post-marketing study

FDA Moves to Remove Black Box Warnings from Menopausal Hormone Therapies

4 weeks ago talkbio0Tagged Black Box Warning, estrogens, Hormone replacement therapy, Hormone Therapy, labeling change, Menopausal symptom, Menopause, Progestins, United States Food and Drug Administration, women 's health

FDA; menopause; hormone therapy; black box warning; HRT; estrogen; progestogen; labeling change; women’s health; menopausal symptoms

FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults

2 years ago talkbio0Tagged Anemia, Approved, Black Box Warning, Chronic Kidney Diseases, Daprodustat, Effectiveness, Hemoglobin concentration result, Jesduvroq, Oral Medication, post-marketing safety, Safety, United States Food and Drug Administration, vadadustat, Vafseo

Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data