AbbVie breaks new ground for IL-23 drug Skyrizi in IBD

June 20, 2024

Category: News

Skyrizi (risankizumab) was previously already cleared by the FDA for adults with moderately to severely active Crohn’s disease, active psoriatic arthritis, and moderate to severe plaque psoriasis. The approval in UC is based on the results of a 12-week induction study called […]

Pfizer setback brings questions for Duchenne gene therapy ahead of Sarepta decision

June 13, 2024

The failure of a Pfizer medicine for Duchenne muscular dystrophy adds new uncertainty around the effectiveness of gene therapy for the muscle-wasting condition, days before the Food and Drug Administration is expected to decide on expanding use of a similar […]

FDA advisers back updating COVID shots to target JN.1 virus family

June 6, 2024

A group of advisers to the Food and Drug Administration on Wednesday unanimously recommended that COVID-19 vaccines be updated to cover coronavirus strains with a family known as JN.1 ahead of the fall. The committee, which had originally been scheduled […]

FDA, Regulations

FDA Rescinds Ban on Juul E-Cigarettes

June 7, 2024


A ban on Juul e-cigarettes has been reversed, the U.S. Food and Drug Administration announced Thursday. Why? The agency said it needs to review both new court decisions and updated data from the vape maker. While the company’s e-cigarettes are […]

FDA, Regulations

FDA Panel Says No to MDMA as Treatment for PTSD

June 5, 2024


A U.S. Food and Drug Administration advisory panel on Tuesday voted against recommending the psychedelic MDMA for the treatment of post-traumatic stress disorder (PTSD). In a 10-1 vote, the panel determined the evidence amassed so far fails to show the […]