Every day, hospitals throughout the U.S. transfuse blood or blood components, such as platelets, to save the lives of people who are in car crashes, and victims of fires and other emergencies.
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
MMJ is currently engaged in litigation with the Drug Enforcement Administration (DEA). The company contends that the DEA has ...
On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® ...
We are proud to offer the only hands-free, wire-free, and app-free test solution.” Proven Clinical Accuracy SANSA’s initial FDA clearance in 2024 validated accuracy against gold-standard ...
At the same time, the small molecule market is projected to grow significantly over the next decade, fueled by a renewed focus on patient-centric drug discovery and innovation in areas like ...
Roche, the parent company of Indianapolis-based Roche Diagnostics, said it received FDA clearance to sell a new test to help determine a patient’s risk of an often untested but common ...
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the US Food and Drug Administration to reduce certain risks associated with ...
Broccoli florets sold in Walmart stores across 20 states that were recalled over bacterial contamination fears have been given the U.S. Food and Drug Administration (FDA)'s highest risk level.
(Scott Olson/Getty Images) In the final days of the Biden administration, the Food and Drug Administration proposed a front-of-package food label that is eye-catching and informative and would ...
NEW YORK – Abbott has received 510(k) clearance from the US Food and Drug Administration for its cardiac function test intended to help diagnose heart failure. The Alere NT-proBNP assay for the ...
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