Topic: Food and Drug Administration
Food manufacturers rushed to recall products made with hydrolyzed vegetable protein (HVP) after the U.S. Food and Drug Administration said it found Salmonella Tennessee in one company’s supply of the ingredient, widely-used used as a flavor enhancer in many processed foods, including soups ...
ImmunoGen Inc. said Monday the Food and Drug Administration and European regulators gave the company's potential cancer drug IMGN901 "orphan drug" status. Orphan drug status is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives in the U ...
Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc. said Monday the potential abuse-resistant painkiller Acurox met key goals in a pivotal study. The companies said the drug candidate met all five key goals of abuse-resistance, compared with equivalent doses of oxycodone HCI. Acurox contains oxycodone, a morphine derivative that is ...
ISTA Pharmaceuticals Inc. said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. 16. The drug is a once-per-day version of Xibrom, a drug that is already on the market but is intended to be used ...
