Quest gains FDA clearance for Simplexa C difficile molecular test
The test, which uses a proprietary chemistry that eliminates the need for nucleic-acid extraction, is performed on liquid or unformed human stool samples and detects the toxin B
The US Food and Drug Administration (FDA) is set to review Kowa Pharmaceuticals America’s new drug application (NDA) for K-911, an investigational once-daily eye drop aimed at reducing intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients.