This expanded approval makes Sonu the first FDA-approved, drug-free solution for nasal congestion due to allergic and nonallergic rhinitis in children ages ≥12 years.

The Food and Drug Administration said approved UroGen Pharma’s (URGN) Zusduri for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The agency pointed ...

Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat ...

(RTTNews) - Gilead Sciences Inc. (GILD) announced that the U.S. Food and Drug Administration has approved Yeztugo (lenacapavir)-the company's injectable HIV-1 capsid inhibitor-as pre-exposure ...

GILD wins FDA approval for Yeztugo, the first and only twice-yearly injectable PrEP for HIV prevention in the United States.

The launch of the injection faces potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts.

That’s why innovative treatments like ZUSDURI are essential, especially for those adult patients with recurrent low-grade, intermediate-risk NMIBC.” ...

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from ...

ZUSDURI consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release RTGel ® technology. ZUSDURI has been designed for potent tumor ablation.

Merck’s shot will compete against a similar blockbuster treatment from Sanofi and AstraZeneca called Beyfortus.