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发布时间: 2025-06-04 09:57:18北京青年报社官方账号
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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

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The US Secret Service said it is reviewing an incident in which an agent blocked a CBS News reporter on Tuesday from questioning Jared Kushner, the President's son-in-law and a senior White House advisor, about the disappearance of Saudi journalist Jamal Khashoggi.In video posted to Twitter by the journalist, Errol Barnett, a US Secret Service agent physically prevented him from questioning Kushner. When Barnett explained that he was a member of the press, the agent replied, "I don't give a damn who you are. There's a time and a place."In a statement provided to CNN, a spokesperson for the US Secret Service said the agency was "aware of the video" posted by Barnett. 682

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The White House has issued a new warning to CNN's Jim Acosta, saying his press pass could be revoked again at the end of the month.In response, CNN is asking the U.S. District Court for another emergency hearing."The White House is continuing to violate the First and 5th Amendments of the Constitution," the network said in a statement Sunday. "These actions threaten all journalists and news organizations. Jim Acosta and CNN will continue to report the news about the White House and the President."Last Friday CNN won a temporary restraining order, forcing the White House to restore Acosta's press access to the White House for 14 days. Judge Timothy J. Kelly ruled on Fifth Amendment grounds, saying Acosta's right to due process had been violated. He did not rule on CNN's argument about First Amendment violations.Later that same day, the White House sent Acosta a formal letter outlining a "preliminary decision" to suspend his pass again once the restraining order expires. The letter cited his conduct at President Trump's November 7 press conference.The letter was signed by two of the defendants in the suit, press secretary Sarah Sanders and deputy chief of staff for communications Bill Shine.The letter signaled that the Trump administration wants to continue fighting Acosta, despite the round one setback in court, rather than seeking an out-of-court settlement.It looked like an effort to establish a paper trail that will empower the administration to boot Acosta again at the end of the month.In a court filing on Monday, CNN's lawyers said the network and Acosta "remain hopeful" that the parties "can resolve this dispute without further court intervention."But the new letter from Shine and Sanders is an "attempt to provide retroactive due process," the lawyers said.So CNN and Acosta are seeking a hearing on a preliminary injunction "for the week of November 26, 2018, or as soon thereafter as possible," according to Monday's filing.Such an injunction could be in effect for much longer, thereby protecting Acosta's access to the White House.Lawyers were already expected to be back in court this week to discuss the timeline for further proceedings. 2186

  

The Sarasota (Fla.) County School District confirmed they are looking into a racially offensive promposal that was posted to social media.A spokesperson for the district confirmed the Riverview High School senior posted a picture that they worry will be a disruptor to the school and student safety. The post made to Snapchat reads, "If I was Black I'd be picking cotton, but I'm white so I'm picking U 4 Prom?"The district said they have not concluded if the 18-year-old will be banned from prom as it's an ongoing investigation. Sarasota County Schools also said they sent a text alert to parents Monday morning about the situation and that they plan to have more information late Monday. The student, who Scripps station WFTS in Tampa is not identifying, also posted an apology to social media. The following message was sent to parents and students on Monday morning:  930

  

The South Korean government says thousands of BMWs will be banned from the country's roads after some vehicles caught fire.The German automaker is facing a public relations crisis in South Korea over the fires, which it has blamed on a problem with the cars' exhaust systems.BMW recalled more than 100,000 vehicles in South Korea last month and has been carrying out emergency inspections. It expanded the checks to Europe last week.As of late Monday, more than 27,000 of the affected BMWs in South Korea still hadn't been checked, according to the South Korean government."Our citizens are deeply concerned," Transportation Minister Kim Hyun-mee said Tuesday. She ordered local authorities to ban people from driving any of the potentially fire-prone BMWs that haven't been brought in for checks. 805

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