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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. . . . → Read More: FDA Approves Skin Infection Drug

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. . . . → Read More: FDA Developing Digital Device Certification Process

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. . . . → Read More: Supreme Court Cuts Biosimilar Waiting Time

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. . . . → Read More: Trial Begins of Freeze-Dried Blood Plasma

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. . . . → Read More: Trial to Test Spherical Nanotech Brain Cancer Drug

$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. . . . → Read More: $2 Billion Biotech Licensing Deal Cancelled

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. . . . → Read More: FDA Warns Cancer Fraud Product Providers

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. . . . → Read More: FDA, Emulate to Test Organs-on-Chips for Drug Toxins

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. . . . → Read More: FDA Shown Approving New Drugs Faster than Europe

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. . . . → Read More: NIH Funds Seen Boosting Industry Patents