Viome, a company transforming health through personalized nutrition based on individual biology, today announces it will collaborate with precision health leader, Helomics, to study the link between the gut microbiome and ovarian cancer.
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 Food and Drug Administration.
Neurotrope Inc. (Nasdaq: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today issued a statement on Biogen Inc.'s decision to discontinue its global Phase 3 trials of aducanunab in Alzheimer's disease.
The Food and Drug Administration is looking toward a future where combustible cigarettes are not addictive and do not harm as many people as are currently affected by nicotine and additive chemicals.
The FDA has accepted the petition for review and designated it as FDA 2019-P-1236.
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Zimmer Biomet becomes first company in the world with 510(k) clearance for Brain, Spine and Knee offerings on one robotic platform
Getting effective treatments for diseases and conditions to people as quickly as possible while guaranteeing their safety and efficacy, as well as protecting the safety of trial subjects, has always been a delicate balancing act for the U.S. Food and Drug Administration (FDA), the federal agency responsible for the safety of pharmaceuticals and medical devices, among other things.
The U.S. Food and Drug Administration estimates that nearly 6 million Americans have heart failure — the organ can’t keep up with their bodies’ needs.
A global company has had its third test cleared by the U.S. Food and Drug Administration which this month approved GenePOC’s Strep A assay, which provides in vitro diagnosis of Strep A infections within an hour.
Neuronix Ltd. announced that the U.S. Food and Drug Administration (FDA) Neurological Devices Advisory Committee met on March 21 to consider data and receive public comment about the neuroAD™ Therapy System, a non-invasive medical device for the treatment of mild-to-moderate Alzheimer's disease.
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Proposed rule would require breast density reporting, enhance the FDA’s ability to enforce mammography facilities’ compliance with standards
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The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
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The U.S. Food and Drug Administration approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.
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If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of end-stage kidney disease when added to current standard of care
Twelve prescription drugs were recalled in January and February to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
MAVENCLAD is the first oral MS treatment to provide two years of proven efficacy with a maximum of 20 days of treatment
Novel, effective endobronchial valve treatment now used by physician at hospital in Philadelphia
Patients living with non-radiographic axial spondyloarthritis, an often undiagnosed, chronic, painful and debilitating disease, now have an approved, clinically validated treatment
Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration ("FDA") for Rykindo®, completed on March 28. Rykindo® (LY03004) Risperidone Extended-release Microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States.
The Europa Pedicle Screw System received FDA 510(k) approval at the end of March.