The Latest Breaking News from FDA

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced Monday it will voluntarily and temporarily pause all U.S. shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, effective July 22.

Moderna Inc.’s (NASDAQ:MRNA) stock has surged approximately 37% in the last month but has dipped around 15% year to date.

Abivax SA (NASDAQ:ABVX) stock is skyrocketing on Wednesday after the clinical-stage biotechnology company announced overwhelmingly positive topline results from its Phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials for oral obefazimod (ABX464) in adult patients with moderately to severely active ulcerative colitis.

OFA Group (NASDAQ:OFAL) experienced an increase in its stock value after hours on Tuesday. The company’s stock value surged by 69.94% to $2.94.

For Chris Christenberry, CEO of Rejuvaskin, skin health goes beyond skincare buzzwords and marketing trends, but is rooted in medical necessity.

President Donald Trump teased the announcement last week, but Coca-Cola finally confirmed it Tuesday: a version of Coke’s trademark cola sweetened with cane sugar will be released in the U.S. this fall

Altria was an earlier investor in Juul. Will its FDA approval be good news for the Altria’s NJOY brand?

The U.S. Food and Drug Administration appointed George F. Tidmarsh on Monday as director of the Center for Drug Evaluation and Research (CDER).

According to a new U.S. Congressional Budget Office analysis, President Donald Trump’s 2026 budget plan proposes cuts to the National Institutes of Health that could significantly reduce the number of new drugs entering the market.