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.
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.
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]
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
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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.
Expects Enrollment of Phase I Trial to Begin in the Third Quarter of 2019
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
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.
The U.S. Food and Drug Administration recently approved a drug that costs $2.1 million and it’s a potential cure for a childhood disorder that afflicts children under 2 years of age.
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The U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.
The U.S. Food and Drug Administration is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age.
