Recent FDA decisions added new options for dermatologists involved in treating patients with psoriasis, bullous pemphigoid and advanced skin cancer. This FDA recap highlights recent approvals in April ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to PathAI for its digital pathology image management ...

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 ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

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

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 ...