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The US Food and Drug Administration approved two cancer treatments, Vitrakvi and Xospata, this week after expedited reviews.Vitrakvi, approved Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker)."The FDA said in a statement that it is the second approved cancer treatment that is based on a tumor biomarker instead of the place in the body where the tumor originated.Vitrakvi will be used for the treatment of solid tumors that have an NTRK (neurotrophic receptor tyrosine kinase) gene fusion that do not have a known resistance mutation, that are not metastatic or where surgical removal is likely to lead to severe morbidity, and that have no alternative treatments or have progressed after treatments.NTRK genes are rare but occur in many types of cancer, the FDA said, such as mammary analogue secretory carcinoma and infantile fibrosarcoma.Xospata tablets, approved Wednesday, are for the "treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.Alongside the tablets, the agency also approved a diagnostic to detect the mutation."Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in the statement.AML is a rapidly progressing cancer that affects the numbers of normal blood cells and calls for continuous transfusions, the FDA said.Both treatments were granted Priority Review designation.Priority Review, established in 1992, means the FDA aims to review the drug or treatment within six months, opposed to 10 months for a standard review."A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," the FDA says.Both treatments also received?orphan drug?designation, a status granted to drugs for rare diseases or conditions. 2261
The Senate on Wednesday will hold a hearing regarding the safety of vaccines, which will feature appearances by Surgeon General Dr. Jerome Adams and National Institutes of Health Director Dr. Francis Collins.The hearing, hosted by the Senate HELP Committee, will discuss the role of vaccines in preventing infectious disease outbreaks and protecting public health.Wednesday's hearing will also include information on a potential COVID-19 vaccine.Top U.S. health experts like Dr. Anthony Fauci say they are cautiously optimistic that there will be enough evidence to grant Emergency Use Authorization to top vaccine candidates by the end of 2020. However, recent polls indicate that some Americans remain skeptical about vaccines.A recent CBS News poll indicates that just 21% of American voters would receive a COVID-19 if one were made available at no cost. That's down from about 30% earlier this year. Two-thirds of those polled say they feel a vaccine would be "rushed" if a vaccine were made available this year.Fauci has said that if a potential vaccine is 75% effective against the virus, it still may not be effective in promoting inoculation levels necessary for "herd immunity" in the U.S. due to Americans' ongoing skepticism about vaccines.Nine vaccine makers banded together to sign a pledge on Tuesday to say that they will not seek Emergency Use Authorization for their vaccine candidates until scientific methods prove they are safe for widespread use. 1476

The Republican mayor of a Kansas town resigned on Tuesday saying that she "no longer felt safe" in the position due to threats she received while attempting to institute a mask mandate.Dodge City Mayor Joyce Warshaw submitted a letter informing the city of her immediate resignation on Tuesday, according to the city's website.According to the Washington Post, Warshaw was thrust into the national spotlight last Friday, when USA Today published a feature story on Dodge City's struggle to contain COVID-19. According to the article, 1 in 10 people in the town of 27,000 had contracted the virus by the time Warshaw instituted the mask mandate on Nov. 16.Though at least a dozen people in the small town had died, USA Today reported that the local police department chose not to enforce the mandate and that few in the city were actually complying with the order.But Warshaw says that Dodge City's defiance went beyond ignoring the rules. She told the Washington Post on Tuesday that threats toward her and her family prompted her resignation."They were loud, and they were aggressive, and they frightened me and my family," Warshaw told the Post. "There's a strong part of me that wants to say they are only words. But people are angry right now, and I don't know that for sure."Warshaw said she received numerous anonymous voicemails from angry constituents."...the messages grew more frequent and aggressive," the Post reported. "Burn in hell. Get murdered. One person simply wrote, 'We're coming for you.'"Warshaw, who was serving in her second stint as the town's mayor, said in her resignation letter that it was the threats that led to her stepping down."Life has dealt out many challenges in our world that have perhaps caused many people to act inappropriately but I do not feel safe in this position anymore and am hopeful in removing myself this anger, accusations and abuse will not fall on anyone else and will calm down," she wrote.Warshaw isn't the first public official to resign amid threats during the COVID-19 pandemic. In June, Ohio Department of Health Director Dr. Amy Acton submitted her resignation after leading the state's fight against the virus for several months.While Acton stated in her resignation letter that she was seeking to spend more time with her family, she regularly received threats from Ohioans angered by public health measures she took to prevent the spread of the virus. Protesters even accosted Acton at her home.In September, hours after Ohio Gov. Mike DeWine named Dr. Joan Duwve as Acton's replacement, Duwve removed herself from consideration for "personal reasons." 2625
The University of Texas Athlete Alumni are in absolute opposition of racism in any form and are engaged in meaningful collaboration to enact change. We are united in our support for current student athletes.#UTXAA#ITooAmTexas#BurntOut#WeAreOne pic.twitter.com/B9HTMJ0hde— Fozzy Whittaker (@FozzyWhitt) June 16, 2020 324
The US Food and Drug Administration announced on Wednesday that southwest veggie stuffed sandwiches sold at exclusively at Aldi have been recalled due to suspected Listeria monocytogenes and Salmonella contamination. The sandwiches were sold under the brand name "Fit and Active" and have production dates of Julian code: 20027230003106:15 BEST BY FEB 09 2019 and Julian code: 20027235003115:13 BEST BY FEB 14 2019.The affected sandwiches were sold in Alabama, Connecticut, Delaware, Florida, Georgia, Kentucky, Massachusetts, Maryland, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Vermont and West Virginia. The FDA said that no illnesses were reported in connection with these products and this recall has been initiated as a precautionary measure.Customers should discard the sandwiches, or return them to the place of purchase for a refund. 985
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