The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously reported, the FDA sent letters to Moderna and Pfizer/BioNTech in April ...

A common drug used for inflammatory skin conditions may hold the key to treating both alcohol addiction and pain sensitivity. That’s what scientists at a leading research institute have found.

Belimumab is now the first and only subcutaneous biologic therapy approved for at-home administration in pediatric lupus nephritis.

The FDA has approved an updated label for Breyanzi and Abecma removing the REMS programs and reducing certain patient monitoring requirements.

FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety program requirements.

The FDA approved lenacapavir, an HIV prevention drug based on University of Utah biochemist Wesley Sundquist's research. Developed by Gilead Sciences, lenacapavir binds HIV's protein shell ...

With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is frustrated by the delay of approved treatments in the rare disease ...

The seventh FDA-approved CAR T-therapy is Aucatzyl, an Autolus Therapeutics cell therapy engineered with properties intended to improve safety.

Yeztugo showed promising results in clinical trials. One study involving women in Africa reported 100% efficacy, with zero HIV infections.

PathPresenter, a leading Image Management System and workflow platform for digital pathology, has received U.S. Food and Drug Administration (FDA) 510 (k) clearance for the PathPresenter Clinical ...

Merck & Co., Inc. (NYSE: MRK) is one of the 10 Best Value Stocks to Buy According to Billionaires. The company announced that the US FDA approved ENFLONSIA™ (clesrovimab-cfor) for the prevention ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines.