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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 unemployment rate has dipped below 4 percent for the first time since 2000.The United States added 164,000 jobs in April, the Labor Department reported Friday. That was slightly below what economists expected. Unemployment dropped to 3.9 percent, the lowest since December 2000."The employment situation continues to surprise everyone," said Robert Frick, chief economist with Navy Federal Credit Union. "Getting down to 3.9 is quite a marker."Wages grew 2.6 percent from a year earlier. That was also slightly below expectations.The report indicates another month of solid job growth for an economy that has been expanding for almost nine years — the second-longest streak on record.Hiring gains in April were broad. Professional and business services added 54,000 jobs, health care added 24,000, and manufacturing posted an increase of 24,000 jobs.The mining sector added 8,000 jobs, extending its gains. Employment in mining has risen by 86,000 since October 2016.The wage growth number seemed unlikely to alarm Wall Street, which has been worried in recent months about inflation. Stock futures were little changed after the report came out.Inflation is closing in on the Federal Reserve's 2% target, gasoline is heading toward a gallon, and companies are reporting cost pressures. Faster inflation could force the Federal Reserve to raise interest rates more quickly than planned.Frick believes unemployment will keep falling as businesses offer more attractive wages and benefits to fill openings."There's still hundreds of thousands of more people who will enter the workforce," he said. "I think we can get down to 3.5 percent."If unemployment falls much further, it will reach territory not seen in half a century. Unemployment fell as low as 3.8 percent in April 2000, in the waning days of the technology boom. The last time it was lower than that was 1969. 1898
The U.S. Centers for Disease Control and Prevention reported Monday that there are 155 patients under investigation this year for acute flaccid myelitis, a condition that that can cause paralysis and mostly affects children.Of these, 62 have been confirmed by the CDC in 22 states, and the remainder continue to be investigated.Acute flaccid myelitis, also called AFM, is a rare but serious condition that affects the nervous system -- specifically, the area of the spinal cord called gray matter. It affects fewer than one in a million people each year across the country, the CDC estimates.The number of patients under investigation is up from 127 patients a week ago, though no new confirmed cases have been reported.The average age of patients confirmed to have the condition is just 4 years old, and more than 90 percent of cases overall occur in children 18 and younger, according to Dr. Nancy Messonnier, director of the agency's National Center for Immunization and Respiratory Diseases. 1003
The Trump administration has reportedly reversed a decision made earlier in the day to deny sending relief to California for several wildfires that have scorched the state. Wildfires in California have burned a record-breaking 4 million acres in 2020, with many still burning. In a tweet Friday afternoon, California Governor Gavin Newsom said “Just got off phone with @realDonaldTrump who has approved our Major Disaster Declaration request.” 451
The Republican nominee for a US House seat in Illinois has said the September 11 terrorist attacks were an inside job and that singer Beyonce Knowles has ties to the Illuminati.Bill Fawell is running against incumbent Democratic Rep. Cheri Bustos in Illinois' 17th District, where she won by 20 points in 2016 even though the district also voted narrowly for Donald Trump. Fawell won his uncontested primary in March. He has not reported any fundraising to the Federal Election Commission, per publicly available records.A KFile review reveals Fawell, a real estate broker, pushed conspiracy theories in blogs and his 2012 book, "New American Revolution."In his book, Fawell pushed a conspiracy theory that 7 World Trade Center collapsed as part of a controlled demolition and the attacks were a plot to destroy documents."Go to YouTube and punch in 'Building #7' It's the third building that went down with the twin towers on 9/11," Fawell wrote. "Nothing hit this building, not a thing, and it fell entirely upon its own. If it looks like a standard commercial implosion demolition, it's because that is exactly what it is.""It's interesting to note that the clandestine branch of the CIA was housed on the top floor," he added. "No personnel were lost, but any and all documents were destroyed, just like a giant shredder. The Pentagon was hit in a wing being remodeled (but few people), that held a mountain of paperwork regarding 1 trillion dollars which the Secretary of Defense, Donald Rumsfeld, was having trouble accounting for. That mountain of paperwork became a pile of ash."In a February 2013 post on the blog of a political action committee he established in 2012 called Elect a New Congress, Fawell said that Beyonce's husband, rapper Jay-Z, "has a long history of serving up the godless Illuminati" and shared a YouTube video that speculated that Beyonce's upcoming halftime performance at the Super Bowl would have Illuminati symbolism.The Illuminati is a secret society that serves as the basis for a popular conspiracy theory that alleges that many of the world's leaders and celebrities are masterminding world events.In the same blog post, Fawell said that the previous Super Bowl's halftime show, performed by Madonna, was satanic and influenced by the Illuminati. He also called Madonna a "narcissist skank with the crooked teeth."In an interview with CNN, Fawell stood by his blog posts and the theories he espoused on them. He said that Jay-Z and Beyonce expressed their support for the Illuminati in their videos, and that singer Taylor Swift had as well.In explaining his rationale that 7 World Trade Center didn't collapse on its own, he said, "There's no way that 1,500-degree jet fuel can melt steel that requires 2,500-degree temperatures to melt." He also acknowledged that he didn't expect any support from the national Republican Party apparatus.The Illinois Republican Party did not respond to a request for comment.Another Illinois Republican nominee for a House seat, neo-Nazi Arthur Jones, has been rejected by national Republicans and the state party for denying the Holocaust.In a 2014 post, Fawell speculated that New York City was going to be destroyed in a false flag attack by the deep state in either the year 2016 or 2017."New York City is going to be destroyed in the biggest, baddest false flag attack ever made by any organization upon the American People in a Pearl Harbor redux," Fawell wrote. (False flag attacks are acts designed by perpetrators to look like they were carried out by other individuals or groups.)He said that the attack would be made in an attempt to drag America into war, and that financial institutions were already withdrawing money from New York in preparation for the supposed attack.In another post in 2014, he wrote that then-President Barack Obama created false flag attacks to shore up support for his foreign policy intervention against ISIS.In addition to alleging conspiracies, Fawell used sexist and racist slurs against politicians.In one 2013 post he called former Secretary of State Colin Powell an "Uncle Tom" and called former Secretary of State Hillary Clinton a "bitch" as well as a witch.He also regularly called Obama "Barry Soetoro" and sometimes called him "Barry Goddamn Soetoro Barack Hussain (sic) Obama."When Obama lived in Indonesia as a child he sometimes was known as Barry Soetoro, as Soetoro was his stepfather's last name. Many conspiracy theorists allege that Soetoro is his real last name and use it to argue that he was not born in the United States.The-CNN-Wire 4578