Today, AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) microarray. The Mosai ...

Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, ...

NS Pharma, Inc. (NS Pharma) a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to NS-229, ...

The US FDA is currently reviewing its pharmaceutical ... Most importantly, the FDA intends to actively discourage the use of logos, bars, stripes, watermark graphics, lines, and symbols on ...

according to an FDA report.The recall includes 864 12-packs — a total of 10,368 cans. FILE - In this Oct. 14, 2019 photo a truck with the Coca-Cola logo, behind left, maneuvers in a parking lot ...

The Food and Drug Administration is suspending a quality control program for its food testing laboratories as a result of ...

U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies ...

The recall has been categorized as “Class II,” meaning any contaminated product could cause “temporary or medically reversible adverse health consequences,” according to ...

Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk ...

The Food and Drug Administration is scrambling to hire contractors to replace fired employees who helped plan thousands of ...

Equillium (EQ) announced that the company has received feedback from its Type D meeting with the FDA to discuss the regulatory pathway for ...

The proficiency testing program of the FDA’s Food Emergency Response Network is designed to ensure consistency and accuracy across the agency’s network of about 170 labs that test food for ...