Phase 3 ADMIRAL trial showed patients treated with XOSPATA demonstrated longer Overall Survival than those who received salvage chemotherapy
Arizona company claims their products can treat Lyme disease, diabetes, Parkinson’s disease and more, but have not been approved for any use
The ZIKV Detect 2.0 IgM Capture ELISA has been authorized for marketing by the Food and Drug Administration for detection of Zika virus immunoglobulin.
Over 2,000 U.S. laboratories ranging from small hospitals to large medical centers have been affected and notified by the U.S. Food and Drug Administration that the Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzer are now under a Class 1 recall.
Submission Follows Productive Pre-NDA Meeting and Marks On-time Execution of First of Two NDA Submissions Planned for 2019
Improved accuracy in identifying bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV) and trichomoniasis (Trichomonas vaginalis, TV) will enable more targeted treatment for women
Cadent Therapeutics, a company focused on the development of therapies to improve the lives of patients with movement and cognitive disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAD-1883, an investigational treatment for spinocerebellar ataxia (SCA), a genetic disorder characterized by progressive loss of coordination, slurred speech, difficulty controlling eye movements and cognitive dysfunction.
The Food and Drug Administration granted full approval to nearly 800 generic drugs in fiscal year 2018, a 90 percent increase over the same time period four years ago, according to a recent analysis by PricewaterhouseCoopers LLP.
