4/4/2023 Gohibic (757KB) (reissued April 12, 2023) Gohibic is authorized for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical […]

Image On December 23, 2021, President Biden signed into law (Public Law 117-79), the “Accelerating Access to Critical Therapies for ALS Act” (ACT for ALS).  The […]

Docket Number: FDA-2024-D-0803 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research It is important to establish an […]

On This Page Date: May 7 – 8, 2024 Day1: Tue, May 7 9:00 AM – 5:00 PM ET Day2: Wed, May 8 9:00 AM – […]

Summary Company Announcement Date: March 12, 2024 FDA Publish Date: March 12, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Silicone […]

For Immediate Release: March 12, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Allergic rhinitis — also known as hay fever — is a very common condition that occurs as an inflammatory response to a person breathing in an […]

Generally, patients prefer to take drugs by mouth (orally).1 Solid oral drugs, such as capsules and tablets, are common because they are cost-effective to make, and […]

Frailty is an aging-related syndrome of cumulative physical and physiological decline, which can include symptoms such as weakness and fatigue, greater medical complications, and lower tolerance […]