FDA Approves New Antibiotic for Multiple Bacterial Infections
U.S. Food and Drug Administration
The FDA granted the approval of Zevtera® to Basilea Pharmaceutica International Ltd.
Drug Approval
FDA Approves First Treatment for NASH-Related Liver Scarring
U.S. Food and Drug Administration
The FDA granted the approval of Rezdiffra to Madrigal Pharmaceuticals
FDA Approves First Drug Therapy for Desmoid Tumors
U.S. Food and Drug Administration
The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.
FDA Approves Recombinant Enzyme to Treat Rare Blood Clotting Disorder
U.S. Food and Drug Administration
Adzynma safely and effectively “filled in” for the mutated ADAMTS13 enzyme in patients with cTTP
FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases
U.S. Food and Drug Administration
Wezlana has similar safety and efficacy as its reference product and is a cost-effective alternative for chronic inflammation
FDA Approves Steroid-Like Drug for Duchenne Muscular Dystrophy
Children's National Hospital
Vamorolone offers a new treatment option with fewer side effects
FDA Approves New Therapeutic for Myelodysplastic Syndromes
U.S. Food and Drug Administration
Tibsovo can be used with FDA-approved companion diagnostic RealTime IDH1 Assay to detect and treat MDS
FDA Approves First Biosimilar to Treat Multiple Sclerosis
U.S. Food and Drug Administration
Tyruko® has been shown to safely mitigate and manage inflammation in autoimmune conditions like Crohn’s disease
FDA Approves First Oral Treatment for Postpartum Depression
U.S. Food and Drug Administration
Multicenter clinical trials demonstrated the efficacy of Zurzuvae in women with PPD
FDA Approves New Drug to Prevent RSV in Babies, Toddlers
U.S. Food and Drug Administration
Beyfortus proved to be safe and efficacious in trials with infants at varying degrees of risk for RSV infection