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 ...

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

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 ...

BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) has announced an updated timeline for submitting its Biologics ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...

Clinical trials have shown that six-monthly injections of lenacapavir are almost 100 percent protective against becoming ...

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market ...

The U.S. Food and Drug Administration has revealed plans to launch a national priority voucher program aimed at reducing the ...