Approvable designations
Approvable designations
• Sitaxsentan (Thelin, Encysive Pharmaceuticals) for the treatment of pulmonary arterial hypertension
Fast-track designations
Priority review
• Infliximab (Remicade, Centocor) for pediatric Crohn's disease
Orphan drug designations
• Cell-permeable peptide (AM-111, Auris Medical) for acute sensorineural hearing loss
Novo Nordisk Terminates Collaboration with Hims & Hers
June 23rd 2025The FDA had resolved the shortage of Wegovy in April, and telehealth providers were advised to stop selling compounded semaglutide products. Novo Nordisk said that Hims & Hers continues to offer these compounded drugs.
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