The Novavax COVID-19 Vaccine has received an expansion of the emergency use authorization (EUA) from the FDA. The expanded EUA allows the vaccine to be administered as a two dose primary series for children aged 12 through 17. The vaccine was previously authorized under an EUA for adults 18+. Read more about the announcement.
Millions of Americans will soon have access to lower cost hearing aids, thanks to a final rule from the FDA aiming to improve access to them. The rule creates a category of OTC hearing aids, which allows a patient, ages 18+, with mild to moderate hearing impairment to purchase a hearing aid from a pharmacy or online retailer without a medical exam, prescription, or adjustment by an audiologist. Read more.
Humira may face competition from multiple generics in 2023. But, immunology medications aren’t the only biosimilars coming into the market in the next few years. Cardinal Health has compiled a report of more than 40 other biosimilars that we may see by 2030. Read Cardinal’s report here.
The Food and Drug Administration on Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that received significant federal funding to produce the shot.
The vaccine will be a new option for Americans as vaccination rates stagnate. The vaccine is authorized as a primary immunization series for adults, rather than a booster. However, the shots can’t be administered until the CDC signs off on the recommendation later this month. Read more.
It’s a win for pharmacies, which had been pushing for the FDA to allow them to prescribe the medication, saying that it would ultimately expand access to the antivirals.
Paxlovid is authorized for the treatment of “mild-to-moderate” COVID-19 in adults and pediatric patients that have tested positive and are considered to be at high risk of developing severe disease.