Tag: FDA
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FDA Approves Skin Infection Drug
The U.S. Food and Drug Administration approved a new drug that treats serious bacterial skin infections, including those often resistant to current antibiotics.
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FDA Developing Digital Device Certification Process
The U.S. Food and Drug Administration expects to unveil a new procedure for certifying digital medical devices that the agency says should speed their entry to the market.
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Supreme Court Cuts Biosimilar Waiting Time
The U.S. Supreme Court ruled yesterday that makers of biologic drugs similar to branded originals need not wait an additional 6 months to begin marketing their products.
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Trial Begins of Freeze-Dried Blood Plasma
A clinical trial is underway testing the safety and practicality of using a person’s own freeze-dried blood plasma for transfusions, substituting for frozen or liquid plasma.
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Trial to Test Spherical Nanotech Brain Cancer Drug
An early-stage clinical trial will soon begin testing spherically-shaped nanoscale particles to treat glioblastoma, an aggressive form of brain cancer.
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$2 Billion Biotech Licensing Deal Cancelled
A licensing deal with a potential value of more than $2 billion between two biotechnology companies for a new breast cancer drug was cancelled on Friday.
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FDA Warns Cancer Fraud Product Providers
The Food and Drug Administration sent warning letters to 14 companies in the U.S. that the agency says are selling products fraudulently claiming to prevent, diagnose, treat, or cure cancer.
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FDA, Emulate to Test Organs-on-Chips for Drug Toxins
A joint venture between Food and Drug Administration and a developer of chip devices simulating human organs, is evaluating the chips as a way to test new drugs for toxic effects.
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FDA Shown Approving New Drugs Faster than Europe
An analysis of regulatory actions in the U.S. and Europe, shows the U.S. Food and Drug Administration approves more new therapies and faster than the European Medicines Agency.
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NIH Funds Seen Boosting Industry Patents
An analysis of grants issued by National Institutes of Health shows a large percentage of those grants, directly or indirectly, result in patented technologies in industry.