Novartis’ bid to expand the company’s $2.1 million-per-patient gene therapy Zolgensma to more spinal muscular atrophy patients faces a possible delay after U.S. regulators requested another study in older children getting the drug via a spinal infusion.
Sinovac Biotech plans to start a clinical trial of the Chinese vaccine maker’s experimental coronavirus vaccine with children and adolescents in September, widening the company’s test on a shot that is already in the final stage of study with adults.
Children and young people are far less likely than adults to get severe cases of Covid-19 infection, and death from the pandemic disease among children is exceptionally rare, according to published UK research.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
The HBA hosts the webinar Back to School 2020 – Pandemic Parenting for Working Parents.
The U.S. government said pharmacists would be allowed to administer routine vaccines to children, calling a drop in immunization from lockdowns aimed at curbing the spread of the coronavirus a “public health threat.”
The number of new Covid-19 cases among children in the United States rose 40% in the last two weeks of July, according to a report released just weeks before tens of millions of American students are scheduled to begin the new school year.
The United States Food and Drug Administration approved Bayer’s Lampit (nifurtimox) for use in pediatric patients for the treatment of Chagas disease caused by Trypanosoma cruzi.
The U.S. Food and Drug Administration issued a Complete Response Letter regarding DBV Technologies’ Biologics License Application (BLA) for investigational Viaskin Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
Results of a pivotal phase III study of Supernus Pharmaceuticals’ SPN-812 (viloxazine extended-release capsules) were published in the journal Clinical Therapeutics.