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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 U.S. Geological Survey is monitoring the recent eruption of the Kilauea Volcano in Hawaii and has made photos and videos of it available to the public.Small cracks began appearing on May 1 following a powerful earthquake, and Kilauea erupted May 4, sending lava onto surrounding roadways. The USGC said on Sunday night, May 6, the volcano's summit lava lake had dropped significantly, and was roughly 220 meters below the crater rim.An overnight video from the main affected neighborhood, Leilani Estates, shows lava erupting from a fissure and advancing north. The lava flow continued to advance several hours after the fissure eruption diminished, the USGS said.In another video (attached to this article), a lava flow can be seen moving on Makamae Street in the Leilani Estates around 9:30 a.m. local time on Sunday, May 6.By Sunday night, at least 10 fissures had opened, and 26 homes had been destroyed, CNN reports. The active venting of lava and hazardous fumes was ongoing.As of Monday morning, the USGS still had a current volcano alert level of "warning" in effect, and the code color is orange."Residents should remain informed and heed Hawaii County Civil Defense closures, warnings, and messages," the USGS website states. Alerts may be found here.Kilauea last erupted in 1983. 1327

The star of the Netflix documentary "Tiger King" Joe Exotic sued the United States Justice Department Wednesday because they rejected his request for a presidential pardon.According to court documents obtained by CBS11 and Courthouse News, lawyers for Exotic, whose real name Joseph Maldonado-Passage, argued that the rejection isn't valid because Acting Pardon Attorney Rosalind Sargent-Burns didn't give his official request to President Donald Trump himself.According to the six-page complaint filed in federal court in Fort Worth, Exotic's legal team named Sargent-Burns because she allegedly never gave President Trump a formal recommendation, which according to the lawsuit, she's required to do.Currently, Maldonado-Passage is serving a 22-year prison sentence in Fort Worth after he was found guilty in April 2019 for animal cruelty and trying to hire someone to murder Carole Baskin, who's a big-cat rights activist.The complaint also names Donald Trump Jr. as a supporter, CBS11 reported. 1006
The Rev. Pat Conroy, the chaplain at the US House of Representatives, has rescinded his resignation in a letter, obtained by CNN, following a week's worth of lawmakers from both parties questioning House Speaker Paul Ryan's request that Conroy step down."At this time, and upon advice of counsel, I herby retract and rescind said resignation for the reasons that follow," Conroy writes in the letter dated Thursday and addressed to Ryan.Conroy, a Jesuit priest, resigned April 15 after he spent nearly seven years praying at the outset of House sessions. He wrote two versions of his resignation letter, which were also obtained by CNN from a congressional source. In the first version, he wrote that Ryan, who is Catholic, should consult with his chief of staff on a resignation date, but the second version stated his last day would be May 24. 853
The Senate has passed its long-stalled legislation that would overhaul how sexual harassment complaints are made and handled on Capitol Hill and would hold members of Congress personally responsible for paying such settlements out of their own pockets.The legislation moved forward following a deal reached by Missouri Republican Sen. Roy Blunt and Minnesota Democratic Sen. Amy Klobuchar, and praised by leaders of both parties in the Senate.The bill now goes back to the House of Representatives, which passed its version in February and where the expectation is that there will be a conference committee to work out the differences between the two bills after Congress returns from its weeklong Memorial Day recess.The differences between the House's and Senate's versions of the legislation include the language used in describing when a member would be required to pay for settlements -- and when they would not -- and the reporting of settlements.California Republican Rep. Jackie Speier, one of the chief negotiators of the House's bill said that there is "disappointment" in Senate's bill among some members on both sides of the aisle in the House."We will go to conference and hopefully we can iron out some of those differences," Speier said Thursday on CNN's "New Day."There also is criticism of the Senate's bill among some outside advocacy groups, which have written to Senate Majority Leader Mitch McConnell and Senate Minority Chuck Schumer expressing concern that the House bill became essentially too watered down in the Senate's negotiations."This bill contains numerous provisions that are contrary to key principles we've previously articulated, falls short of an acceptable compromise, and may have unintended negative consequences," says a letter sent to Senate leaders signed by the American Civil Liberties Union, Equal Pay Today, The Leadership Conference on Civil and Human Rights National Women's Law Center and Public Citizen.Additionally, these groups say they see "significant differences" between the House and Senate bills and are "deeply concerned" that "neither senators nor key stakeholders have been given adequate time to fully vet the bill."Congressional sources tell CNN there are numerous areas that the discussion will center on when the two sides meet to work out a compromise.Among the chief areas of concern: The provision for members being held personally responsible in the Senate bill states that they have to pay out of pocket only for sexual harassment, not for any awards that may be ordered for sex discrimination or any other kind of discrimination. Some fear that could provide a loophole for members who are accused of harassment to settle with a victim for sex discrimination, knowing that they won't be required to pay the settlement and it will instead come out of a US Treasury fund.Additionally, there is concern that in the Senate's legislation would empower and involve the Ethics Committee more so than the House's. The Senate version would give the chair and ranking member of the committee the authority to overrule settlement repayments. The House bill would create a third-party investigatory process instead. 3183
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