A multiple ascending dose study of a second generation formulation of ganaxolone is expected to begin in the second quarter of 2023.
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Inspire therapy is a fully implanted neurostimulation device that consists of a small generator, a sensing lead, and a stimulation lead.
Yet another infant formula maker has recalled some of its product over concerns of contamination with Cronobacter sakazakii bacteria.
This is the first FDA-approved systemic therapy for first-line treatment of pediatric patients with low-grade glioma with a BRAF V600E mutation.
This age group is now eligible to receive the booster dose at least 2 months after they complete primary vaccination with 3 doses of the monovalent vaccine.
Previously, the treatment had been approved for patients 1 year of age and older.
Recent increase in pediatric iGAS cases was mainly in children without underlying medical conditions
Sudden unexplained infant death rates increased among non-Hispanic Black infants, but not overall
The approval was supported by data from the randomized, double-blind, placebo-controlled phase 3 LAVENDER study.
Opioids accounted for 24.1 percent of substances contributing to deaths in 2005 and 52.2 percent in 2018
The sNDA is supported by data from the phase 3 DINAMO trial, which include patients 10 to less than 18 years of age with type 2 diabetes who are currently receiving metformin, insulin, or both.
Eplontersen is an investigational ligand-conjugated antisense medicine.
Significant reductions seen in RSV-related infections, RSV-related hospitalizations for three monoclonal antibodies versus placebo
Stimulated C-peptide secretion partially preserved with verapamil versus placebo at 52 weeks after diagnosis of type 1 diabetes
The application is supported by data from the pivotal phase 3 B-SIMPLE4 study which included 891 patients 6 months of age and older with molluscum contagiosum.
M-M-R II, Varivax, and ProQuad are supplied in single-dose vials as lyophilized vaccine for SC or IM injection after reconstitution.
Genetic sequencing linked the infection to bacteria from a breast pump used at home
To assess the potential risk, the FDA is working with manufacturers of neonatal incubators and evaluating data from their products.
No signs of higher risk seen for developmental disorders