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2 days ago | 
conexiant.com | Kathryn Wighton
Dupilumab is now the first and only FDA-approved targeted therapy for bullous pemphigoid, demonstrating sustained disease remission and reduced corticosteroid dependence in a pivotal trial. The U.S. Food and Drug Administration (FDA) has approved dupilumab (Dupixent) as the first targeted therapy for adults with bullous pemphigoid (BP), a rare, chronic autoimmune skin disease characterized by pruritus, blistering, and widespread skin involvement.
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4 days ago | 
conexiant.com | Kathryn Wighton
For the first time, children as young as 5 with active lupus nephritis can now receive belimumab treatment at home via a newly approved subcutaneous autoinjector. The U.S. Food and Drug Administration has approved a 200 mg/mL subcutaneous autoinjector formulation of belimumab (Benlysta) in pediatric patients aged 5 years and older with active lupus nephritis (LN) who are receiving standard therapy.
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1 week ago | 
conexiant.com | Kathryn Wighton
A brief computerized test combined with a newly developed scoring system may help stratify older adults by risk of early Alzheimer's disease pathology and potentially reduce reliance on positron emission tomography imaging.
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2 weeks ago | 
conexiant.com | Kathryn Wighton
mRESVIA is now approved in the U.S. for adults aged 18 to 59 with chronic health conditions. The approval expands its prior indication that was limited to adults aged 60 years and older. Adults aged 18 to 59 years with chronic conditions—including cardiovascular and pulmonary diseases—are increasingly recognized as a high-risk population for respiratory syncytial virus (RSV)-related complications, including respiratory tract disease.
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2 weeks ago | 
conexiant.com | Kathryn Wighton
Mavyret achieved a 96% cure rate in patients with acute hepatitis C following an 8-week oral treatment regimen. The FDA has expanded the indication for glecaprevir/pibrentasvir (Mavyret) in its approval as the first and only oral, 8-week, pangenotypic regimen for both acute and chronic hepatitis C virus (HCV) infection in patients aged 3 years and older without cirrhosis or with compensated cirrhosis.
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2 weeks ago | 
conexiant.com | Kathryn Wighton
Enflonsia is the first RSV preventive approved for infants that uses a single fixed dose regardless of weight and offers protection throughout a full respiratory syncytial virus season. The FDA has approved enflonsia (clesrovimab-cfor), a long-acting monoclonal antibody developed by Merck, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are entering their first RSV season.
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3 weeks ago | 
conexiant.com | Kathryn Wighton
From the first at-home human papillomavirus test and a biosimilar approved for broad immunologic indications, to new options in mitral valve replacement, chronic obstructive pulmonary disease care, and Alzheimer’s diagnostics, May’s U.S. Food and Drug Administration decisions spanned cardiology, pulmonology, neurology, and more. Here’s a comprehensive overview of the month’s most key decisions.
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3 weeks ago | 
conexiant.com | Kathryn Wighton
In a case-control cohort, Guardant Health’s Shield multi-cancer detection test demonstrated 98.6% specificity and 75% sensitivity across eight tumor types. The test has since received FDA Breakthrough Device designation. The methylation-based blood assay is designed for screening multiple cancer types—specifically bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreatic cancers—in asymptomatic adults aged 45 years or older at average risk.
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3 weeks ago | 
conexiant.com | Kathryn Wighton
Moderna’s newly approved mNEXSPIKE vaccine demonstrated a 13.5% higher relative efficacy than Spikevax in adults aged 65 years and older, according to phase 3 trial data. The FDA has approved Moderna’s COVID-19 vaccine mNEXSPIKE (mRNA-1283) for adults aged 65 years and older and patients aged 12 to 64 years with one or more underlying risk factors, as defined by the CDC.
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1 month ago | 
conexiant.com | Kathryn Wighton
Eton Pharmaceuticals announced U.S. Food and Drug Administration approval of Khindivi (hydrocortisone) Oral Solution for replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency. Khindivi is the first U.S. Food and Drug Administration (FDA)-approved oral liquid formulation of hydrocortisone and is available in a 1 mg/mL concentration.
