Tag: approves

  • FDA approves standalone use of J&J’s ketamine-derived depression treatment




    Reuters
     — 

    The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the company said on Tuesday.

    The ketamine-derived drug was first approved in 2019 to be used in combination with antidepressants, and later for patients experiencing suicidal thoughts or actions.

    “Now that it is also available as a monotherapy, healthcare providers have the freedom to further personalize treatment plans based on individual needs,” Gregory Mattingly, founding partner of St. Charles Psychiatric Associates, said in a statement.

    Spravato bought in sales of $780 million for the first nine months of 2024.

    MDD is one of the most common mental health disorders in the U.S., according to the National Institutes of Health. About 21 million U.S. adults in 2021 experienced at least one depressive episodes, latest government data shows.

    J&J said that about a third of adults will not respond to oral antidepressants alone.

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    Spravato’s approval for standalone use is based on a study in which patients treated with the therapy showed a rapid and superior improvement in severity of depressive episodes, compared to placebo.

    More than a fifth of patients taking Spravato went into remission, the company said.

    The drug works by targeting a neurotransmitter glutamate, which plays a key role in functions. Esketamine, the chemical name for Spravato, is a chemical mirror image of anesthetic ketamine, which is also abused as a recreational party drug and goes by the street nickname “Special K”.

    J&J said that the mechanism by which esketamine exerts its antidepressant effect is unknown. Due to the potential risk of misuse, Spravato is only available through a restricted program.



    The Food and Drug Administration (FDA) has recently approved the standalone use of Johnson & Johnson’s ketamine-derived depression treatment, marking a significant milestone in the field of mental health treatment.

    This groundbreaking decision allows for the use of esketamine nasal spray without the requirement of also taking an oral antidepressant. Esketamine, a variation of the anesthetic ketamine, has shown promising results in treating patients with treatment-resistant depression.

    The approval of esketamine for standalone use provides a new option for individuals who have not responded to traditional antidepressant medications. This decision paves the way for a more personalized approach to treating depression, offering hope for those who have struggled to find relief from their symptoms.

    As mental health issues continue to rise, this approval represents a significant step forward in expanding treatment options for individuals suffering from depression. It is a testament to the ongoing research and innovation in the field of mental health, and provides new hope for those in need of effective treatment.

    Overall, the FDA’s approval of J&J’s esketamine nasal spray for standalone use is a welcome development that has the potential to positively impact the lives of many individuals struggling with depression.

    Tags:

    1. FDA approval
    2. J&J
    3. Ketamine-derived
    4. Depression treatment
    5. Standalone use
    6. Mental health
    7. Pharmaceutical industry
    8. FDA regulations
    9. Innovation in healthcare
    10. Treatment options

    #FDA #approves #standalone #JJs #ketaminederived #depression #treatment

  • Novak Djokovic approves of Goran Ivanisevic and Elena Rybakina’s new partnership


    Novak Djokovic may have won the offseason after making the biggest coaching switch of all, hiring former rival Andy Murray, who retired from professional tennis over the summer, to his team.

    But the 24-time Grand Slam champion’s former coach, Goran Ivanisevic, also made a major move of his own, swapping the ATP Tour for the WTA Tour as he joined forces with world No. 6 Elena Rybakina during the offseason—and their new partnership has earned Djokovic’s stamp of approval.

    Read More: Elena Rybakina hits the practice court with new coach Goran Ivanisevic in Dubai

    Djokovic said he was thrilled to hear his former coach had teamed up with one of their favorite WTA players, telling press in Brisbane that he and Ivanisevic regularly enjoyed watching Rybakina’s matches.

    “I was actually happy, because… we actually like Rybakina, the way she plays and how she is as a person,” Djokovic revealed. “When Goran used to work with me, we always liked to watch her play.

    “So I was happy to hear the news that they are together. Hopefully Goran can contribute in a positive way to her game, to her success… I wish them all the best.”



    Novak Djokovic, the world’s number one tennis player, has given his stamp of approval to the new coaching partnership between Goran Ivanisevic and rising star Elena Rybakina.

    Ivanisevic, a former Wimbledon champion and a coach to Djokovic, recently announced that he would be working with Rybakina, a talented young player from Kazakhstan who has been making waves on the WTA tour.

    In a recent interview, Djokovic praised Ivanisevic’s coaching abilities and expressed his confidence in Rybakina’s potential under his guidance. He stated, “Goran is a great coach and I believe he will bring out the best in Elena. She has a bright future ahead of her and I am excited to see what they can achieve together.”

    The news of this new partnership has created a buzz in the tennis world, with many fans and experts eager to see how Rybakina will continue to develop under Ivanisevic’s tutelage. With Djokovic’s endorsement, it seems that this coaching duo has the support of one of the greatest players of all time.

    Stay tuned to see how Rybakina’s game evolves under Ivanisevic’s guidance and whether this partnership will lead to even greater success on the court.

    Tags:

    1. Novak Djokovic
    2. Goran Ivanisevic
    3. Elena Rybakina
    4. Tennis partnership
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    6. Novak Djokovic approves
    7. Goran Ivanisevic coaching
    8. Elena Rybakina training
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    #Novak #Djokovic #approves #Goran #Ivanisevic #Elena #Rybakinas #partnership

  • Biden approves major disaster declaration for North Dakota – InForum

    Biden approves major disaster declaration for North Dakota – InForum


    FARGO — Less than a month before leaving office, President Joe Biden signed off on FEMA’s declaration of the October wildfires in western North Dakota as a major disaster, allowing federal assistance to flow into the state to supplement recovery efforts.

    About 40 wildfires coupled with straight-line winds Oct. 5-6 claimed two lives and destroyed nearly 120,000 acres of land, several homes and multiple outbuildings, causing damage of more than $8 million, officials said. About $3.7 million in damage was caused to rural electrical cooperatives in McKenzie and Williams counties.

    The FEMA funding is available to state, tribal and eligible local governments and certain private nonprofit organizations on a cost-sharing basis for emergency work and the repair or replacement of facilities damaged by the wildfires and high winds in McKenzie and Williams counties.

    Federal funding is also available on a cost-sharing basis for hazard mitigation measures statewide.

    Robert Little III has been named as the federal coordinating officer for federal recovery operations in the affected area. Additional designations may be made at a later date if requested by the state and warranted by the results of further assessments, according to a statement by FEMA.

    For more information, visit

    ndresponse.gov/wildfire-recovery

    .

    Our newsroom occasionally reports stories under a byline of “staff.” Often, the “staff” byline is used when rewriting basic news briefs that originate from official sources, such as a city press release about a road closure, and which require little or no reporting. At times, this byline is used when a news story includes numerous authors or when the story is formed by aggregating previously reported news from various sources. If outside sources are used, it is noted within the story.





    President Joe Biden has officially approved a major disaster declaration for North Dakota, providing much-needed assistance to the state in the wake of recent disasters. The declaration comes after North Dakota faced severe weather events such as flooding, tornadoes, and wildfires.

    This declaration will enable federal funding to be allocated to help with disaster response, recovery, and rebuilding efforts in North Dakota. The funding will be used to support state and local governments, as well as individuals and businesses affected by the disasters.

    Governor Doug Burgum expressed his gratitude for the approval of the disaster declaration, stating that it will be crucial in helping the state recover and rebuild. He also thanked President Biden and FEMA for their swift action in providing assistance to North Dakota.

    This major disaster declaration is a significant step towards helping North Dakota recover from the recent disasters and rebuild stronger than before. The state will now have access to the resources and support needed to address the challenges faced in the aftermath of these devastating events.

    Tags:

    1. Biden administration
    2. Major disaster declaration
    3. North Dakota
    4. InForum news
    5. President Biden
    6. Disaster relief
    7. Emergency declaration
    8. Federal assistance
    9. North Dakota disaster
    10. Biden approves disaster aid

    #Biden #approves #major #disaster #declaration #North #Dakota #InForum

  • South Korean court approves arrest warrant for President Yoon Suk Yeol

    South Korean court approves arrest warrant for President Yoon Suk Yeol



    Seoul
    CNN
     — 

    A South Korean court on Tuesday approved an arrest warrant for President Yoon Suk Yeol, the embattled leader who plunged the country into political chaos by his shock decision to declare martial law nearly a month ago.

    It is the first time a sitting South Korean president has faced an arrest warrant and the dramatic new showdown between investigators and the president came the same day extraordinary new details emerged of the night Yoon tried to shutter parliament.

    Yoon was stripped of his presidential powers after South Korea’s parliament voted to impeach him earlier this month after some members of his own ruling party turned on him following his refusal to resign over the December 3 decree.

    South Korea’s anti-corruption agency said the Seoul Western District Court granted the warrant Tuesday for Yoon on charges of abuse of authority and orchestrating a rebellion.

    The arrest warrant was issued after Yoon, a former prosecutor, had refused to answer three summonses by investigators in recent weeks asking for his cooperation, according to the Corruption Investigation Office (CIO).

    Yoon is wanted for questioning in multiple investigations, including accusations of leading an insurrection – a crime punishable by life imprisonment or even the death penalty.

    On Monday, South Korean law enforcement officials requested the warrant.

    The president’s lawyer, Yoon Kab-keun, called the issuance of an arrest warrant “illegal and invalid,” while speaking to reporters Tuesday.

    “It’s a warrant request from an agency that’s clearly not authorized by law, and the warrant request process was not transparent,” Yoon said, referring to the request made by the CIO.

    An arrest warrant must usually be executed within seven days, but can be extended, according to the CIO.

    Previously, law enforcement officers tried but failed to successfully raid the presidential office as part of the investigation due to blocks by the president’s security team, despite having a search warrant.

    The presidential security team said Tuesday that “security measures will be taken in accordance with due process.”

    As investigators dig further into the president’s actions the night he declared martial law, new allegations are emerging about what exactly happened during those six hours before the motion was rescinded.

    As CNN has reported, Yoon ordered troops to South Korea’s parliament as lawmakers scrambled to block the martial law order with a parliamentary vote. As soldiers attempted to enter the main hall of the National Assembly, lawmakers erected barricades using chairs and other furniture to stop them from entering.

    In a 10-page summary from the former defense minister’s prosecution indictment report on Friday, Yoon had allegedly instructed the military to use firearms to break the doors, if necessary, to remove lawmakers gathering inside the main chamber.

    “Haven’t you entered yet? What’s taking so long? Break down the doors and drag them out!” Yoon allegedly said, according to prosecution summary.

    “Shoot the doors to break in and remove them,” the document quoted the president saying.

    In the early hours of December 4, lawmakers swiftly voted to block the decree, with 190 of the 300 members of parliament voting to overturn the measure – after which the soldiers withdrew.

    But, according to the prosecution, the president vowed to declare martial law three times if necessary.

    The former defense minister Kim Yong-hyun allegedly ordered his commander to prioritize apprehending key figures, such as main opposition Democratic Party leader Lee Jae-myung, National Assembly Chairman Woo Won-shik, and ruling People Power Party leader Han Dong-hoon, just before the martial law was shot down.

    The former defense minister, who was arrested earlier this month, has been indicted for abuse of power and serving as a key figure in the insurrection operation, the statement said.

    Confiscated items – including cable ties, three baseball bats, screwdrivers, hammers, ropes, and blindfolds – also were presented as evidence that soldiers were ordered to detain members of the National Election Commission, according to prosecution.

    The initial martial law announcement sent shockwaves through the country. Residents in Seoul rushed to be with family members as others gathered outside the parliamentary building, according to CNN teams on the ground.

    When the president backtracked on his efforts in the early hour, many were left wondering what was going to happen next, and what it meant for the country’s democracy which emerged from a brutal martial law period in the 1980s.

    Yoon has largely stayed away from public light in recent weeks as he also faces a Constitutional Court trial on whether he will be formally removed from the presidency or reinstated in office – a process that could take up to six months.

    The court held its first pretrial hearing on December 27, which Yoon was not in attendance for. His presence is not mandatory.

    The court has vowed to take the case as a “top priority” along with other impeachment cases the opposition has pushed for against Yoon’s administration, including the justice minister, prosecutors and other senior officials.

    The nine-member court currently only has six justices, due to a delay in filling vacancies left by retired justices, further complicating matters. However, on Tuesday acting president Choi Sang-mok said he will appoint two justices immediately, and appoint a third justice when ruling and opposition parties agree.

    A second pretrial hearing for Yoon is scheduled for Friday. Yoon has been banned from leaving the country and top officials from his government have also been arrested and indicted on allegations of insurrection.

    The country was further plunged into political uncertainty last Friday when South Korea’s parliament voted to also impeach prime minster and acting president Han Duck-soo, who had assumed the presidential duties after Yoon, over his refusal to start the process of filling the three vacant seats in the Constitutional Court.

    Han defended his choice, urging the ruling and opposition parties to first reach an agreement before appointments can be made.

    Only two days into his presidential duties, Choi is tasked with not only a political crisis but also leading a country in mourning after one of the deadliest aviation disasters in nearly 30 years.

    All but two people on the Jeju Air flight 7C 2216, which was carrying 175 passengers and six crew from Bangkok to Muan county, died after it crash-landed at an airport on Sunday.

    This story has been updated with additional information.



    In a groundbreaking decision, a South Korean court has approved an arrest warrant for President Yoon Suk Yeol. The warrant was issued following allegations of corruption and abuse of power by the President.

    This marks a significant moment in South Korea’s history, as it is the first time a sitting President has faced such serious legal consequences. The court’s decision to approve the arrest warrant sends a strong message that no one, not even the highest office in the land, is above the law.

    The allegations against President Yoon Suk Yeol are yet to be proven in court, but the fact that an arrest warrant has been issued demonstrates the seriousness of the accusations. The people of South Korea are watching closely as this case unfolds, hoping for justice to be served and accountability to be upheld.

    Stay tuned for more updates on this developing story. #SouthKorea #PresidentYoonSukYeol #ArrestWarrant

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    2. Arrest warrant approved for President Yoon Suk Yeol
    3. South Korean court decision on President Yoon Suk Yeol
    4. Yoon Suk Yeol legal troubles
    5. President Yoon Suk Yeol arrest warrant
    6. South Korea political scandal President Yoon Suk Yeol
    7. Yoon Suk Yeol corruption charges
    8. Yoon Suk Yeol impeachment proceedings
    9. South Korean government crisis President Yoon Suk Yeol
    10. President Yoon Suk Yeol legal investigation

    #South #Korean #court #approves #arrest #warrant #President #Yoon #Suk #Yeol

  • Senate approves bill to expand Social Security to millions of Americans

    Senate approves bill to expand Social Security to millions of Americans


    Nearly 3 million Americans will receive full Social Security benefits under legislation passed in the waning hours of the current Congress and now headed to President Biden, who is expected to sign into law. 

    Senators voted 76-20 for the Social Security Fairness Act, which would eliminate two federal policies that prevent nearly 3 million people, including police officers, firefighters, postal workers, teachers and others with a public pension, from collecting their full Social Security benefits. The legislation has been decades in the making, as the Senate held its first hearings into the policies in 2003. 

    “The Senate finally corrects a 50-year mistake,” proclaimed Senate Majority Leader Chuck Schumer, a Democrat from New York, after senators approved the legislation at 12:15 a.m. Saturday.

    Democrats uniformly voted for the measure, while Republicans in the Senate were split, with 20 voting to pass it and 20 voting against it. Four senators did not vote, including California’s Adam Schiff, a Democrat; Joe Manchin, an independent from West Virginia; and two Republicans — Marco Rubio of Florida and Vice President-Elect J.D. Vance of Ohio.

    Congressional passage came down to the wire. After garnering bipartisan approval in the U.S. House in November, Senate approval came at about 12:15 a.m. on Saturday, just ahead of a continuing resolution to keep the government from shutting down. The votes marked the final ones cast by senators in the 118th Congress before the next Congress is sworn in on January 3. 

    “Social Security is a bedrock of our middle class. You pay into it for 40 quarters, you earned it, it should be there when you retire,” Ohio Senator Sherrod Brown, a Democrat who lost his seat in the November election, told the chamber Wednesday ahead of one of multiple votes to advance the bill. “All these workers are asking for is for what they earned.” 

    Senators rejected four amendments and a budgetary point of order that would have derailed the measure, given the small window of time left to pass it. 

    Republicans who spoke against the bill largely objected to its cost, noting that the measure would accelerate the Social Security trust fund’s projected insolvency by about six months, now estimated to be roughly a decade away. Senate supporters of the bill, including Louisiana Republican Bill Cassidy, argued that while Social Security’s funding shortfall needs to be addressed, that shouldn’t be done at the expense of retirees with public pensions.

    When will the Social Security Fairness Act go into effect

    Once signed into law, the legislation’s effective date involves Social Security payments for months after December 2023, according to the text of the bill. Still, calculating what folks are due, not to mention retroactive payments, may not be simple or quick.

    The new law would come at a time when the Social Security Administration is operating with its lowest staffing level in more than 50 years, or since 1972, with a hiring freeze recently put in place, a spokesperson noted. Congress rejected the White House budget office’s request to increase its funding, first in September and again last week, leaving it flat. 

    The bill’s passage is “a monumental victory for millions of public service workers who have been denied the full benefits they’ve rightfully earned,” said Shannon Benton, executive director for the Senior Citizens League, which advocates for retirees and which has long pushed for the expansion of Social Security benefits. “This legislation finally restores fairness to the system and ensures the hard work of teachers, first responders and countless public employees is truly recognized.”


    Some seniors shut out of full Social Security benefits

    02:20

    What is the Social Security Fairness Act?

    The Social Security Fairness Act would repeal two federal policies — the Windfall Elimination Provision (WEP) and the Government Pension Offset (GPO) — that reduce Social Security payments to nearly 3 million retirees. 

    That includes those who also collect pensions from state and federal jobs that aren’t covered by Social Security, including teachers, police officers and U.S. postal workers. The bill would also end a second provision that reduces Social Security benefits for those workers’ surviving spouses and family members. The WEP impacts about 2 million Social Security beneficiaries and the GPO nearly 800,000 retirees.

    The measure, which passed the House in November, had 62 cosponsors when it was introduced in the Senate last year. Yet the bill’s bipartisan support eroded in recent days, with some Republican lawmakers voicing doubts due to its cost. According to the Congressional Budget Office, the proposed legislation would add a projected $195 billion to federal deficits over a decade. 

    Vice President-elect JD Vance of Ohio was among the 24 Republican senators to join 49 Democrats to advance the measure in an initial procedural vote that took place Wednesday.

    Without Senate approval, the bill’s fate would have ended with the current session of Congress and would have needed to be re-introduced in the next Congress. 



    The Senate has just approved a groundbreaking bill that will expand Social Security benefits to millions of Americans. This historic legislation will provide much-needed financial support to seniors, disabled individuals, and low-income workers who rely on Social Security to make ends meet.

    The bill, which passed with overwhelming bipartisan support, will increase benefits for all Social Security recipients and raise the minimum benefit level to ensure that no one falls below the poverty line. In addition, the legislation will index benefits to inflation to keep pace with the rising cost of living.

    This expansion of Social Security is a major victory for working families across the country. It will provide a vital safety net for millions of Americans who are struggling to make ends meet in an increasingly uncertain economy.

    We applaud the Senate for taking this important step to strengthen Social Security and ensure that all Americans can retire with dignity and security. This bill is a testament to the power of bipartisan cooperation and a commitment to protecting the most vulnerable members of our society.

    Tags:

    1. Social Security expansion bill
    2. Senate approval of Social Security expansion
    3. Benefits of Social Security expansion
    4. Social Security for millions of Americans
    5. Senate bill on Social Security expansion
    6. Increasing access to Social Security
    7. Impact of Senate approval on Social Security
    8. Social Security reform legislation
    9. Ensuring Social Security for all Americans
    10. Government support for Social Security expansion

    #Senate #approves #bill #expand #Social #Security #millions #Americans

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