What you need to know about the FDA’s most recent novel drug approvals.
FDA Approves New Moderna COVID-19 Vaccine for Older Adults, High-Risk Patients
The new approval is in line with recommendations that suggest booster vaccination for older adults and patients aged 12 to 64 with at least 1 or more underlying risk factors.
Episode 8: Stay in Sync with Innovations in Medication Decision Support
Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.
FDA Approves Hydrocortisone Oral Solution for Adrenocortical Insufficiency
The replacement therapy is indicated for patients 5 years and older, marking the first approval for an oral solution form of hydrocortisone.
FDA Grants Interchangeability Designation to Adalimumab-Bwwd for Humira
This designation follows Hadlima’s low-concentration prefilled syringes and single-dose vials, which were designated in June 2024.
FDA Approves Ustekinumab-Hmny as Biosimilar to Stelara
Ustekinumab is a medication used to treat and manage inflammatory conditions, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.
FDA Approves Roflumilast Foam For Plaque Psoriasis of Scalp, Body
The supplemental new drug application for roflumilast (Zoryve) is approved for adult and pediatric patients 12 years and older.
