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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 US Centers for Disease Control and Prevention warned US consumers on Tuesday to not eat romaine lettuce, as it may be contaminated with E. coli.Thirty-two people, including 13 who have been hospitalized, have been infected with the outbreak strain in 11 states, according to the CDC. One of the hospitalized people developed hemolytic uremic syndrome, a potentially life-threatening form of kidney failure. No deaths have been reported.People have become sick in California, Connecticut, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio and Wisconsin.The Public Health Agency of Canada has identified an additional 18 people who have become sick with the same strain of of E. coli in Ontario and Quebec.If you have any romaine lettuce at home, you should throw it away, even if you have eaten some and did not get sick, the CDC cautioned."This advice includes all types or uses of romaine lettuce, such as whole heads of romaine, hearts of romaine, and bags and boxes of precut lettuce and salad mixes that contain romaine, including baby romaine, spring mix, and Caesar salad," the CDC said in its announcement.All types and brands of romaine lettuce are suspect because no common grower, supplier, distributor or source company has been identified by the CDC.Retailers and restaurants also should not serve or sell any until more is known about the outbreak.Symptoms of E. coli infection, which usually begin about three or four days after consuming the bacteria, can include watery or bloody diarrhea, fever, abdominal cramps, nausea and vomiting, according to the CDC. Most people infected by the bacteria get better within five to seven days, though this particular strain of E. coli tends to cause more severe illness.People of all ages are at risk of becoming infected with Shiga toxin-producing E. coli, according to the US Food and Drug Administration, which is also investigating the outbreak. Children under 5, adults older than 65 and people with weakened immune systems, such as people with chronic diseases, are more likely to develop severe illness, but even healthy children and adults can become seriously ill.Illnesses started in October. This outbreak is not related to a multistate outbreak linked to romaine lettuce this summer.The-CNN-Wire 2311

The Supreme Court has rejected Republicans' last-gasp bid to reverse Pennsylvania’s certification of President-elect Joe Biden’s victory in the electoral battleground. The court without comment Tuesday refused to call into question the certification process in Pennsylvania. Gov. Tom Wolf already has certified Biden’s victory and the state’s 20 electors are to meet on Dec. 14 to cast their votes for Biden. Biden won 306 electoral votes, so even if Pennsylvania’s results had been in doubt, he still would have more than the 270 electoral votes needed to become president.Amid dozens of failed legal challenges since the election, Trump has been meeting with state legislative leaders, including Republican members of the Pennsylvania legislature.A Trump-appointed federal judge was among a three-judge panel that threw out a lawsuit in Pennsylvania. The other two judges were Judge Michael Chagares, a George W. Bush appointee, and Judge D. Brooks Smith, who has been appointed by both GOP and Democratic presidents.“Charges of unfairness are serious. But calling an election unfair does not make it so. Charges require specific allegations and then proof. We have neither here,” 3rd Circuit Judge Stephanos Bibas wrote. Bibas was appointed by Trump to the federal bench in 2017.Last month, a joint statement released by federal and state officials described the presidential election as the “most secure in American history.”The letter was signed by leaders of the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency, the U.S. Election Assistance Commission and the National Association of State Election Directors, among others. The Cybersecurity and Infrastructure Security Agency was established two years ago as a branch of Homeland Security during the Trump administration.In bold, the authors of the statement wrote, “There is no evidence that any voting system deleted or lost votes, changed votes, or was in any way compromised.” This statement matches those from secretaries of state and boards of election throughout the US.In response to the letter, Trump fired US election security head Chris Krebs. 2154

The Supreme Court ruled in favor of Booking.com Tuesday in a landmark trademark case.In an 8-1 decision, the Supreme Court upheld a lower court ruling that determined that Booking.com is not a generic trademark because the term held meaning with consumers.Justice Stephen Breyer, a liberal judge, was the lone dissenting opinion.Other businesses including Cars.com, Dictionary.com, Newspapers.com and Wine.com said the outcome in the case would affect their ability to trademark their names too. 503

The true power of @ChadwickBoseman was bigger than anything we saw on screen. From the Black Panther to Jackie Robinson, he inspired generations and showed them they can be anything they want — even super heroes. Jill and I are praying for his loved ones at this difficult time.— Joe Biden (@JoeBiden) August 29, 2020 325

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