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Top 5 Healthcare Headlines for June 2-8, 2025.
FDA Approves Clesrovimab RSV Immunization for Newborns and Infants
The FDA has approved clesrovimab (Enflonsia) for the prevention of RSV lower respiratory tract disease in infants, based on results from two late-stage clinical trials evaluating its safety and efficacy.
FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV
The FDA has expanded the indication for glecaprevir/pibrentasvir to include treatment of acute hepatitis C virus infection in adults and children aged three years and older, regardless of cirrhosis status.
FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation
Prednisolone acetate ophthalmic suspension 1% has received FDA approval as a topical steroid treatment for steroid-responsive ocular inflammation, with product launch expected later in 2025.
FDA Grants Fast Track Designation to Mavorixafor for Chronic Neutropenia
The FDA has granted Fast Track designation to mavorixafor for the treatment of chronic neutropenia, supporting its ongoing phase 3 evaluation following earlier approval for WHIM syndrome.
Iptacopan (Fabhalta) Hits Primary Endpoint in Phase 3 APPULSE-PNH Trial
Phase 3 data show iptacopan (Fabhalta) is effective and well-tolerated in adults with PNH who transitioned from anti-C5 therapy, achieving key hematologic outcomes and symptomatic improvement.
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