The FDA, disappointed in the manufacturing methods it saw at a Chinese API maker’s facility during a fall inspection, first put Sichuan Friendly Pharmaceutical on its import alert list and has now ...

The label for the diabetes drug Ozempic — which has become popular for weight loss — now acknowledges reports of blocked intestines following use of the medication. The change comes after the Food and ...

Roughly a year after receiving an FDA reprimand at its manufacturing plant in Michigan, Indian drugmaker Piramal Pharma has landed in the regulator’s crosshairs once again. Following an inspection of ...

The United States Food and Drug Administration (U.S. FDA) has issued a Form 483 with two observations to generic drugmaker Dr. Reddy’s Laboratories’ active pharmaceutical ingredients (API) ...

Generic drugmaker Granules India’s active pharmaceutical ingredients (API) manufacturing facility in Bonthapally, Hyderabad, has been issued an observation by the U.S. Food and Drug Administration ...

The secret to enabling early cancer detection could be hidden in the microbiome, and, now, gut-testing startup Viome has the backing of the FDA to prove it. Viome was initially launched as a direct-to ...