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The United States Secret Service said on Monday that following an investigation that closed several streets near the White House due to a suspicious package left in the area of Pennsylvania Avenue and Lafayette Park, the package was deemed "safe."The Secret Service said at 5:40 p.m. ET that H Street NW between 15th and 17th, Pennsylvania Ave between 15th and 17th, and the White house North Fence Line are closed.By 6:10 p.m., the Secret Service allowed streets near the White House to reopen after deeming the package as safe. 592
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 Supreme Court says Justice Ruth Bader Ginsburg has been discharged from a hospital in New York City and has returned home. The court says Ginsburg, 87, is doing well, two days after undergoing a minimally invasive procedure on Wednesday to “revise a bile duct stent” at Memorial Sloan Kettering Cancer Center. The stent had originally been placed last August, when Ginsburg was treated for a cancerous tumor on her pancreas. Ginsburg announced earlier this month that she is receiving chemotherapy for a recurrence of cancer.Stent revisions are common occurrences and the procedure, performed using endoscopy and medical imaging guidance, was done to minimize the risk of future infection, her doctors said, according to a statement.In May, Ginsburg was hospitalized for treatment for a benign gallbladder condition.Ginsburg has also beaten cancer four times after suffering from pancreatic cancer last year. 921
The White House on Wednesday downplayed comments by national security adviser John Bolton, who recently invoked Libya's decision to denuclearize during the Bush administration as a model for US policy on North Korea, potentially placing a planned US-North Korea summit in jeopardy.Hours earlier, a North Korean official said Bolton's remarks were indicative of an "awfully sinister move" to imperil the Kim regime. North Korea stunned Washington on Tuesday by threatening to abandon talks between President Donald Trump and Kim Jong Un if Washington insists on pushing it "into a corner" on nuclear disarmament.Referring to the Libya comparison, White House press secretary Sarah Sanders said Wednesday that she hadn't "seen that as part of any discussions so I'm not aware that that's a model that we're using."I haven't seen that that's a specific thing. I know that that comment was made. There's not a cookie cutter model on how this would work."She continued, "This is the President Trump model. He's going to run this the way he sees fit. We're 100% confident, as we've said many times before, as I'm sure you're all aware, he's the best negotiator and we're very confident on that front."In April, Bolton suggested that the White House was looking at Libya as an example of how it will handle negotiations with North Korea to denuclearize."We have very much in mind the Libya model from 2003, 2004," Bolton said on Fox News. "There are obviously differences. The Libyan program was much smaller. But that was basically the agreement that we made."The US agreed to ease sanctions on Libya in 2003 in exchange for a promise by Moammar Gadhafi to abandon his country's nuclear program. Eight years later, however, Gadhafi was overthrown and killed by rebels backed by Washington.In a statement published late Tuesday by the state-run Korea Central News Agency, Kim Kye Gwan, North Korea's first vice minister of the Ministry of Foreign Affairs, called Bolton's comments indicative of "an awfully sinister move to impose on our dignified state the destiny of Libya or Iraq which had been collapsed due to yielding the whole of their countries to big powers.""It is absolutely absurd to dare compare (North Korea), a nuclear weapon state, to Libya which had been at the initial stage of nuclear development," Kim said. "(The) world knows too well that our country is neither Libya nor Iraq which have met miserable fate."Singling out the national security adviser for personal criticism, Kim said that North Korea had "shed light on the quality of (John) Bolton already in the past, and we do not hide our feeling of repugnance towards him." 2657
The Trump campaign has dropped a central part of its lawsuit that seeks to delay the certification of election results in Pennsylvania, the state which proved to be the tipping point for Joe Biden in clinching the presidency.On Sunday, the Trump campaign dropped a portion of a lawsuit that alleged that more than 600,000 mail-in and absentee ballots were processed without Republican poll-watchers present. The claim has been a central part of President Donald Trump's argument that the 2020 election has been beset by widespread voter fraud.The Trump campaign's lawsuit now only focuses on claims that Republicans were "illegally disadvantaged" because some voters in Democratic-leaning counties were afforded the ability to fix mistakes on their mail-in ballots, a process called "curing." The Washington Post reports that the issue would likely only affect a small number of votes.Ballot curing is a process that takes place in several states. According to The Associated Press, there is no provision in Pennsylvania state law that prevents counties from affording voters the opportunity to cure ballots.Biden currently holds a lead of about 70,000 votes over Trump, with nearly all of the votes counted.Despite his campaign's altered lawsuit, Trump on Sunday continued to claim on Twitter — without providing evidence — that poll watchers "were thrown out of vote counting rooms in many of our States."Late Sunday evening, Trump tweeted, "I WON THE ELECTION!" a claim that quickly prompted Twitter to add a clarification to his message clarifying that "official sources have called this election differently." 1622