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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 Food and Drug Administration has again expanded the list of recalled medications that contain valsartan, used as a component in a set of drugs to treat heart failure and blood pressure.The expanded list was posted Monday.The FDA announced an initial recall in July after lab tests revealed that some drugs could have been tainted with a substance that may lead to a higher risk of cancer. The drug had been recalled in 22 other countries.The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide, but not all drugs containing valsartan are affected. 594
The road to college sometimes has twists and turns, for Rehan Staton, the road to Harvard Law included recovering from injuries, growing up with a single parent, and years as a sanitation worker.Staton’s life changed when he was 8, when his mother left, according to CNN. His father raised him and his brother, reportedly working multiple jobs to make ends meet. Staton struggled in high school, and graduated with the help of a tutor his dad found. An injury before graduating meant an athletic scholarship was out of reach.When his dad suffered a stroke, Staton and his brother took jobs as sanitation workers to support the family. While collecting garbage, Staton found time to attend the University of Maryland.He spent his college years waking up early and collecting garbage before class. Staton says it was because of encouragement from his sanitation coworkers that he kept going to class. He graduated with a history degree and a GPA of 3.84 in December 2018. Staton was profiled in the University of Maryland’s campus paper.Staton wasn’t done. After graduating he took a job to support his dad and didn’t give up on higher education. He applied to 9 schools. His cousin reportedly had the idea to record Staton opening letters from schools he applied to, to capture his reactions. Staton says the admissions process was “super random at times” and encourages people not to “internalize it.”He is now headed to Harvard Law School this fall, and his excitement after years of hard work was caught on camera. His reaction to Harvard is about 6 minutes into the video.There is currently a gofundme account set up to help Staton raise the money needed to attend Harvard. He will reportedly be taking classes online this fall and hopes to be on campus soon. 1771
The Trump administration issued an order on Friday that will attempt to ban Americans from downloading Chinese-owned social media apps TikTok and WeChat beginning Sunday.The order issued by Commerce Department Sec. Wilbur Ross, requires companies like Apple and Google to remove the apps from their online stores by Sunday. It also orders that all U.S. companies cease working with WeChat to transfer funds or process payments in the app.It's currently unclear if Apple and Google will choose to comply with the Commerce Department's order or if they will choose to file a lawsuit to keep the apps in their stores.“Today’s actions prove once again that President Trump will do everything in his power to guarantee our national security and protect Americans from the threats of the Chinese Communist Party," Ross said in a statement. “At the President’s direction, we have taken significant action to combat China’s malicious collection of American citizens’ personal data, while promoting our national values, democratic rules-based norms, and aggressive enforcement of U.S. laws and regulations.”There will be no penalty for those who have already downloaded the app and continue to use it to communicate. However, the order says that messaging on the apps "could be directly or indirectly impaired” by the order.In the case of TikTok, the order stipulates that its parent company, ByteDance, has until Nov. 12 to "resolve" its national security concerns. ByteDance has been in talks to sell its American business with U.S. software company Oracle.Privacy experts have raised concerns about both Chinese-owned apps, saying Americans' personal information could fall into the hands of the Chinese government. In August, Trump signed an order that set a Sept. 20 deadline for the sale of TikTok's U.S. business."Each collects vast swaths of data from users, including network activity, location data, and browsing and search histories," the Commerce Department's order reads. "Each is an active participant in China’s civil-military fusion and is subject to mandatory cooperation with the intelligence services of the CCP. This combination results in the use of WeChat and TikTok creating unacceptable risks to our national security." 2242
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