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.
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.
Improved accuracy in identifying bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV) and trichomoniasis (Trichomonas vaginalis, TV) will enable more targeted treatment for women
Submission Follows Productive Pre-NDA Meeting and Marks On-time Execution of First of Two NDA Submissions Planned for 2019
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.
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.
Arizona company claims their products can treat Lyme disease, diabetes, Parkinson’s disease and more, but have not been approved for any use
Phase 3 ADMIRAL trial showed patients treated with XOSPATA demonstrated longer Overall Survival than those who received salvage chemotherapy
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U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Aliqopa based on follow-up data from the pivotal Phase II CHRONOS-1 study
Expects Enrollment of Phase I Trial to Begin in the Third Quarter of 2019
True Diagnostics, Inc. (True), a leading company for Point of Care Answers, announced that its VeriClear™ Digital Early Result Pregnancy Test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for detecting human chorionic gonadotropin (hCG) levels in women prior to their first missed period.
New Indication Makes VRAYLAR First and Only Dopamine and Serotonin Partial Agonist to Treat the Full Spectrum of Bipolar I Symptoms in Manic, Mixed, and Depressive Episodes
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2[1,2]
Amyotrophic lateral sclerosis, better known as Lou Gehrig’s disease, is an illness that has no FDA approved drug to alleviate the symptoms. In fact, it does not have a cure.
The U.S. Food and Drug Administration recently sent letters to companies that produce homeopathic products claiming they were in violation of current good manufacturing practice (CGMP) regulations.
The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.
The U.S. Food and Drug Administration today approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), the most severe form of SMA and a leading genetic cause of infant mortality.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
