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5 days 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 week 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.
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1 week ago | 
conexiant.com | Kathryn Wighton
The US Department of Health and Human Services (HHS) has advised health care providers to revise treatment protocols for pediatric gender dysphoria following publication of a May 1, 2025, evidence review. The review identified “weak evidence and growing international retreat” from medical interventions including puberty blockers, cross-sex hormones, and surgeries for minors and documented a “risk of significant harm” associated with such treatments.
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1 week ago | 
conexiant.com | Kathryn Wighton
Starjemza has been approved by the Food and Drug Administration following evidence from phase 1 and 3 trials that demonstrated comparable efficacy, safety, and immunogenicity to Stelara.
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2 weeks ago | 
conexiant.com | Kathryn Wighton
The FDA has approved GSK’s anti–interleukin-5 (IL-5) monoclonal antibody mepolizumab (Nucala) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease and an eosinophilic phenotype, the company announced.
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2 weeks ago | 
conexiant.com | Kathryn Wighton
Roflumilast foam 0.3% is now U.S. Food and Drug Administration–approved as a once-daily, steroid-free topical treatment specifically formulated to treat plaque psoriasis across the scalp and body, including hair-bearing areas. The U.S. Food and Drug Administration (FDA) has approved the topical treatment in patients aged 12 years and older.
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2 weeks ago | 
conexiant.com | Kathryn Wighton
NeurAxis, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for an expanded indication of IB-Stim™, a noninvasive neuromodulation device, for the treatment of pediatric functional abdominal pain associated with functional dyspepsia and related nausea symptoms in patients aged 8 to 21 years. This clearance is the first FDA authorization for a treatment specifically indicated for functional dyspepsia and broadens the labeled indication of IB-Stim.
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3 weeks ago | 
conexiant.com | Kathryn Wighton
Interim analysis demonstrated a 6.2-month improvement in median overall survival, with follow-up ongoing. The U.S. Food and Drug Administration (FDA) has approved retifanlimab-dlwr (Zynyz), a PD-1–targeted humanized monoclonal antibody, for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) in combination with carboplatin and paclitaxel.
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3 weeks ago | 
conexiant.com | Kathryn Wighton
The first blood-based diagnostic test to aid in detecting amyloid plaques associated with Alzheimer’s disease has been cleared by the FDA. The U.S. Food and Drug Administration (FDA) has cleared the first blood-based in vitro diagnostic device to aid in the assessment of Alzheimer’s disease.
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3 weeks ago | 
conexiant.com | Kathryn Wighton
The FDA has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only autoinjector formulation of dihydroergotamine for the acute treatment of migraine with or without aura and cluster headaches in adults, according to Amneal Pharmaceuticals. The single-dose autoinjector delivers 1 mg subcutaneously and is designed for self-administration. It does not require refrigeration, assembly, or priming, and is expected to be available for appropriate patients in the second half of 2025.
