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.
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The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant.
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents.
If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of kidney failure when added to current standard of care