The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

Emapalumab is approved for both adults and pediatric (newborn and older) patients with MAS in Still disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.

General Food Labeling Requirements and Labeling-Related Sample Analysis — Domestic and Import” replaces the previous 2010 ...

FDA announced on Tuesday, June 24, 2025, that it has updated Compliance Program 7321.005, now titled General Food Labeling ...

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...

Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates ...

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...

"Eli Lilly receives FDA approval for Amyvid label update" was originally created and published by Pharmaceutical Technology, ...

Although Tissium first demonstrated its polymer material as a cardiovascular sealant, the application that the FDA just ...