Many critical functions of the food division of the Food and Drug Administration have been drastically slowed or entirely stopped since late ...

DexCom DXCM-2.10%decrease; red down pointing triangle received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...

While those equipment and infrastructure problems made up the bulk of the FDA’s criticisms, the regulator also raised concerns with Granules’ manufacturing records. During the inspection ...

The U.S. Food and Drug Administration has announced a recall on popular salad kits sold in several states due to undeclared allergens. Little Leaf Farms is recalling a specific lot code of its ...

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. With a large backlog, we’re anticipating a significant ramping up of inspections in different ...

Get Instant Summarized Text (Gist) An investigational drug, Rhenium Obisbemeda (186RNL), has been shown to more than double the median survival and progression-free time for glioblastoma patients ...

At this year's ASCO congress, news that Trodelvy (sacituzumab govitecan) failed to have a significant impact on overall survival (OS ... Trump's pick to lead the FDA, Martin Makary, was challenged ...

Your survival kit will be unique to your situation. If you're a family with babies or small children, if you have an existing medical condition or a disability, you should consider what you're ...