The FDA originally approved Otulfi as a biosimilar in October 2024 based on clinical data that demonstrated the product was highly similar to Stelara.

The FDA also requested Novavax conduct a phase 4 study in patients aged 50 to 64 years without high-risk conditions for severe COVID-19.

AD109 is a once daily pill that consists of aroxybutynin, an antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor.

The Teal Wand is an at-home vaginal self-collection device intended to test for 14 types of high-risk HPV that have the highest risk for causing cervical cancer.

Brekiya consists of dihydroergotamine mesylate, an ergotamine derivative, in a single-dose autoinjector for subcutaneous administration.

The patient's medical history included obesity, asthma, possible sleep apnea, and a potentially deviated septum.

Nature Made, CeraVe, and Neutrogena placed No. 1 in three or more categories for best OTC product. The companies with the most No. 1 products were Haleon (23), Kenvue Inc. (17), Prestige Consumer ...

New epinephrine nasal spray dosage approved for pediatrics; FDA agree to review semaglutide for weight management; wearable defibrillator cleared to ...

The Food and Drug Administration (FDA) has approved Optison ™ (perflutren protein-type A microsphere) injectable suspension for use in pediatric patients with suboptimal echocardiograms to opacify the ...

The Food and Drug Administration (FDA) has approved Welireg ™ (belzutifan) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced, unresectable, or metastatic ...

RxDx assay as a companion diagnostic to identify c-Met protein expression in non-squamous NSCLC patients eligible for treatment with Emrelis.