A biomedical tool that tricks aggressive brain tumors such as glioblastoma into migrating into an external container rather than throughout the brain has been designated a "Breakthrough Device" by the U.S. Food and Drug Administration ...
Feb 6, 2019
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6474
In 2003, the first year of her fellowship in pediatric oncology, two of Giselle Saulnier Sholler's first three patients had died from neuroblastoma, closely matching the 30% survival rate expected at the time for high-risk ...
Dec 15, 2023
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16
Over the last four decades, insulin manufacturers have extended their periods of market exclusivity on brand-name insulin products by employing several strategies, including filing additional patents on their products after ...
Nov 16, 2023
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18
An international team of researchers has developed a handheld, non-invasive device that can detect biomarkers for Alzheimer's and Parkinson's Diseases. The biosensor can also transmit the results wirelessly to a laptop or ...
Nov 13, 2023
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30
An investigation published by The BMJ raises concerns about a revolving door culture between the US Food and Drug Administration (FDA) and Moderna after two regulators who held oversight roles for COVID vaccines went to ...
Nov 2, 2023
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60
Cedars-Sinai Cancer investigators have identified two promising new treatment options for men with recurrent prostate cancer—both of which helped patients live longer without their disease progressing than the current standard ...
Oct 18, 2023
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44
Lenacapavir, an injection, has been approved by the FDA for multi-drug resistant HIV.
Sep 1, 2023
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23
The U.S. Food and Drug Administration is approving more novel pharmaceutical drugs based on single clinical trials and with less public disclosure about those trials than was the norm just a few years ago, a pair of recent ...
Aug 24, 2023
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99
In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making ...
Aug 17, 2023
3
117
A new digital headset designed to measure alterations in brain function could change decisions about how quickly an athlete is ready to return to play after a concussion. In an evaluation of the device, UC San Francisco researchers ...
Aug 12, 2023
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46
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.
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