News & Articles

The FDA cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly 10 years

Today’s activities are part of ongoing implementation of new authorities for certain over-the-counter drugs

The statement includes a letter to manufacturers, guidance on identifying contaminants in food and next steps the agency will take

The update provides alternative temperature for transportation and temporary storage for frozen vials before dilution

The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020

The U.S. Food and Drug Administration has authorized the first coronavirus test using at-home collection of saliva samples

The U.S. Food and Drug Administration has approved Tabrecta (capmatinib) to treat adult patients with non-small cell lung cancer

Enhertu targets the changes in HER2 that help the cancer grow, divide and spread

Instrument is designed to reduce the number of parts requiring disinfection after use

Adakveo targets key molecule for the prevention of sickle cell pathology

The Barostim Neo System was given a Breakthrough Device designation by the FDA

The U.S. Food and Drug Administration has approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis

Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and signals FDA’s continued focus on facilitating development of new treatments to fight antimicrobial resistant infections