The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
The Food and Drug Administration is looking to women aged 35-64 to “Remove the Risk” of opioids in the household.
The Medical Device Safety Action plan outlines the FDA’s mission to protect public health in a more timely and effective way.
First study of any kind showing a MIGS device achieving a statistically significant reduction in secondary incisional surgery; over 70% of patients remain free of medications
Contrary to past drug company pronouncements, the cost of clinical trials makes up a small fraction of pharmaceutical drug development costs, a new study concludes.
This is the first companion diagnostic to detect gene fusions across all solid tumors; Caris expects to submit for Pre-Market Approval later this year
Results from one of the largest datasets in uterine cancer presented at The American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of its newly redesigned website for Qudexy® XR (topiramate) Extended-Release Capsules.
FDA announces new efforts to protect women's heath and ensure the safety of breast implants
Measles is one of the most contagious respiratory diseases in the world that has the potential to be life-threatening.
Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead.
On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults.
The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age.
Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).
Parents, doctors and other stakeholders are welcoming the approval of a device to help treat children of a certain age with attention-deficit/hyperactivity disorder (ADHD), but with caution.
BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company developing cellular therapies for unmet needs, announced today the issuance of a Notice of Allowance for a patent from the United States Patent and Trademark Office (USPTO) for United States Patent Application No. 15/156,316 for a method of reducing spinal cord injury (SCI)-induced parenchymal cavitation in patients that have suffered an acute spinal cord injury.
Optina Diagnostics announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2).
Seven drugs were recalled in April to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
Robust Clinical Evidence Supports PREVENATM Therapy Effectiveness in Reducing SSIs in a Range of Medical Specialties
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An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a gut-selective mode of action