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.

FDA updates CAR T-cell therapy labels for liso-cel and ide-cel, easing monitoring requirements and expanding access for ...

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

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

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

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

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

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

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).

Adults in the US who want to measure their blood glucose levels using a wearable sensor will soon be able to buy one over-the-counter (OTC) for the first time. The FDA has cleared Dexcom’s Stelo ...