KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary swelling disorder, sending its shares up 33.3% in premarket trading.

Researchers at the School of Chinese Medicine, LKS Faculty of Medicine, the University of Hong Kong (HKUMed), have found that ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

Certain words in your Amazon listings can trigger compliance warnings. Understand how to stay accurate while avoiding policy violations.

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

In a landmark ruling that redefines the boundaries of federal regulatory power, the U.S. Supreme Court has ruled against the Food and Drug Administration (FDA) in a high-profile dispute over its ...

While Kennedy has made the issue one of the FDA’s top priorities, his recent announcement on the phaseout of food dyes depends entirely on companies voluntarily removing the dyes from their products.

The FDA has stopped new clinical trials that export American citizens’ living cells from the U.S. to “China and other hostile countries for genetic engineering and subsequent infusion” back ...

The committee members said they were reaffirming “the essential role FDA plays in determining the safety of food and color additives in the nation’s food and beverage supply.” They also requested that ...

The Food, Drug, and Cosmetic Act of 1938, or FDCA, authorizes the FDA to regulate manufactured products, U.S. District Court Judge Sean Jordan wrote in his opinion, adding that the “FDA has no ...