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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 weekslong search for Mollie Tibbetts, a 20-year-old Iowa student who disappeared while jogging, came to a grisly end Tuesday when a man guided investigators to a body in a cornfield.While authorities have yet to confirm the body is Tibbetts, they arrested Cristhian Bahena Rivera, 24, on first-degree murder charges.The discovery dashed the hopes of family and friends who had scoured Poweshiek and nearby counties as rewards grew to nearly 0,000. Tibbetts, officials said, is believed to have been abducted on July 18 as she went out for an evening jog.Rivera, who's an undocumented immigrant, told them Monday that he saw and pursued her, getting out of his car and running beside Tibbetts. She warned him she would call police, officials told reporters Tuesday.The suspect, who said he blacked out at some point, led authorities to the field Tuesday morning, they said. A body, dressed in Tibbetts' clothing, was covered in corn leaves.It is unclear why Rivera killed Tibbetts, said Rick Rahn, special agent in charge at the Iowa Division of Criminal Investigation."I can't really speak to you about the motive," Rahn said. "I can just tell you it seems that he followed her and seemed to be drawn to her on that particular day and for whatever reason he chose to abduct her." 1294

The Trump administration has closed the Washington Monument because of a recent visit by Interior Secretary David Bernhardt, who tested positive this week for the coronavirus. Interior spokesman Nicholas Goodwin says a couple of monument workers were quarantined as a result of Bernhardt's visit, forcing a staffing shortage and the monument's closure. The Interior Department announced Bernhardt's positive test result for the coronavirus on Wednesday. An advocacy group for parks criticized Bernhardt, saying he had failed to safeguard park employees overall during the pandemic. Goodwin said the interior secretary wore a mask and followed other health guidelines throughout the visit.According to USA Today, Goodwin plans to reopen the monument on Dec. 21. 768

The Special Counsel's Office is hoping to deny an attempt by several media organizations, including CNN, to unseal documents in the Russia probe, by arguing that the documents need to remain private because of the breadth of still-secret parts of the ongoing investigation."The Special Counsel's investigation is not a closed matter, but an ongoing criminal investigation with multiple lines of non-public inquiry. No right of public access exists to search warrant materials in an ongoing investigation," Robert Mueller's team wrote in a filing Wednesday night.The prosecutors wrote in the firmest language yet about how their yearlong investigation into Russian interference in the 2016 US election continues and includes several interconnected parts, some of which may link back to searches of the belongings of former Trump campaign chairman Paul Manafort that were also used to build cases against him unrelated to his work for the campaign.Manafort faces criminal indictments in Virginia and DC federal courts related to his foreign lobbying business from before the campaign. He's pleaded not guilty in both.Prosecutors have previously revealed that the Justice Department directed Mueller to look into allegations that Manafort coordinated with Russians during the campaign, yet they have not previously hinted that others besides Manafort could be central to the Russia probe. Wednesday's court filing acknowledges multiple relationships that are part of investigative threads."The investigation consists of multiple lines of inquiry within the overall scope of the Special Counsel's authority. Many aspects of the investigation are factually and legally interconnected: they involve overlapping courses of conduct, relationships, and events, and they rely on similar sources, methods, and techniques. The investigation is not complete and its details remain non-public," prosecutors wrote.If they were to be unsealed, "warrant materials reveal investigative sources and methods, preliminary factual and legal theories, and evidence that has already been gathered -- including from grand jury processes. They show what has been searched -- including electronic facilities where the search itself is protected by a non-disclosure order -- and indicate what has not been searched. And the dates and volume of warrants reveal an investigation's direction."The Special Counsel's Office said it wouldn't oppose formally unsealing two search warrants that were made public through recent court filings in Manafort's case, though parts of them remain heavily redacted.CNN, along with The Associated Press, Politico, The Washington Post and The New York Times, initially asked the court to unseal all the search warrants used in the investigations and other sealed documents related to Manafort's two federal criminal cases. 2838

The resilience of the students and staff at Marjory Stoneman Douglas High School is obvious. They've resumed classes, and their lives, on a campus where 17 of fellow students and teachers were killed in a mass shooting just over a month ago.And now, they'll turn what's normally a private chronicle of high school life -- a yearbook -- into a public testament to pain and perseverance.For the first time, the high school's yearbook is being made available nationally for purchase. In it, the yearbook staff weave a powerful tale of Marjory Stoneman Douglas' strength and resolve, for the whole world to see."We're still here. We still have games going on. We're still making the yearbook. There's still going to be prom," yearbook adviser Sarah Lerner said in a blog post for Walsworth Yearbooks. "We're a very strong community and we're not letting this stop us."Lerner said at first she was hesitant to share the upcoming yearbook, The Aerie, with the public, because there are student pictures and personal stories in it. But she ultimately decided that opening up the yearbook to people outside the school would let them see how much pride the students have in their school."I hope they see how hard the kids have worked and how much love has gone into this book," Lerner said. "I hope that they see all of the wonderful things that we do here, before the (shooting) and since."'It's our story'The Aerie will include coverage of the shooting, pictures from vigils and memorials, a story on students dyeing their hair in honor of the victims, pieces on the surviving students' political activism and highlights from the week they returned to the school.In a special section, each of the mass shooting's 17 victims will be profiled."We have a story to tell and it's our story. No one else will tell it better than we will, because we lived it," Lerner said.People interested in buying a copy of the yearbook can go to yearbookforever.com to place an order. 1966

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