FDA
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New data submitted to the U.S. Food and Drug Administration suggests Pfizer's COVID-19 vaccine is stable for two weeks in freezers around -15 °C (5 °F), allowing for significantly more flexibility in shipping and storage methods.
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Health authorities in the UK have recommended extending dosing schedules for COVID-19 vaccines, claiming one dose offers short-term protection despite trials only testing two-dose regimes. US authorities call the change risky and unproven.
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The US Food and Drug Administration has approved a genetically modified pig for human consumption and therapeutic use. The pig is engineered to be free of a certain sugar molecule responsible for severe allergic reactions in some people.
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Biotech company Moderna has revealed more data from its Phase 3 COVID-19 vaccine trial, reporting the vaccine is 94.1 percent effective at preventing COVID-19. An FDA review evaluating Emergency Use Authorization is now scheduled for December 17.
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Pfizer and BioNTech have announced their large Phase 3 COVID-19 vaccine trial is complete. The trial has reportedly met all its primary endpoints and the vaccine is claimed to be 95 percent effective.
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A phase 2 clinical trial of a cholesterol-reducing drug called evinacumab has reported promising results. In patients with extremely high cholesterol, the drug was able to reduce levels by about half, compared to a placebo.
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The FDA has approved a platform called NightWare, designed to help improve sleep in post-traumatic stress disorder patients suffering from recurrent nightmares. The system is an Apple Watch app that will only be available by prescription.
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The FDA has just approved the first coronavirus-specific antibody treatment for moderate cases of COVID-19. The focused Emergency Use Authorization (EUA) is aimed at newly diagnosed infections at the highest risk of progressing to severe disease.
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An experimental drug has been shown to slow the progression and prolong survival of patients suffering from the neurodegenerative disease ALS. With Phase 2 human trials complete, the company developing the treatment is working to accelerate its approval.
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A new experimental drug could help mitigate some of the dangerous side effects caused by a once-promising diabetes medication. Animal tests suggest the combination treatment is both safe and effective at helping regulate blood sugar levels in diabetics.
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The FDA has approved two new kinds of breast cancer treatments, one targeting HER2-positive cancers and a second for metastatic triple-negative breast cancer. The approval for both treatments was expedited due to the novel coronavirus pandemic.
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After a year of investigation the US Food and Drug Administration (FDA) has completely withdrawn all ranitidine products from the American market. Studies have revealed levels of a carcinogenic compound can increase in the product over time, particularly when stored at high temperatures.