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The US Food and Drug Administration on Thursday announced the approval of?the first generic version of EpiPen.The auto-injector pen delivers the drug epinephrine to patients experiencing a severe allergic reaction that, if untreated, could develop into the life-threatening condition of anaphylaxis. The medication is delivered into a muscle as a single dose, like a shot, through an injector pen with a spring.Allergies from food, bug bites, medications and latex can cause life-threatening reactions.The newly approved generic is made by Teva Pharmaceuticals and offers an alternative for patients who, until now, have been able to use only the brand-name EpiPen made by Mylan. It is approved in a smaller dose for children, as well.There are two other brand products on the market for a severe allergic reaction: Adrenaclick and Auvi-Q.The newly approved option made by Teva is the only approved non-brand option and can be substituted only for Mylan's EpiPen."Today's approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval," FDA Commissioner Dr. Scott Gottlieb said in a statement announcing the approval.In recent years, Mylan came under fire for a price increase that put the product out of reach for many who needed to keep the drug on hand. 1488

The White House on Monday backed down from its threats to revoke Jim Acosta's press pass."Having received a formal reply from your counsel to our letter of November 16, we have made a final determination in this process: your hard pass is restored," the White House said in a new letter to Acosta. "Should you refuse to follow these rules in the future, we will take action in accordance with the rules set forth above. The President is aware of this decision and concurs."The letter detailed several new rules for reporter conduct at presidential press conferences, including "a single question" from each journalist. Follow-ups will only be permitted "at the discretion of the President or other White House officials."The decision reverses a Friday letter by the White House that said Acosta's press pass could be revoked again right after a temporary restraining order granted by a federal judge expires. That letter -- signed by two of the defendants in the suit, press secretary Sarah Sanders and deputy chief of staff for communications Bill Shine -- cited Acosta's conduct at President Trump's November 7 press conference, where he asked multiple follow-up questions and didn't give up the microphone right away."You failed to abide" by "basic, widely understood practices," the letter to Acosta claimed.CNN won the temporary restraining order earlier on Friday, forcing the White House to restore Acosta's press access 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 that the revocation of Acosta's press pass was a violation of his and the network's First Amendment rights.Many journalists have challenged the administration's actions against Acosta, pointing out that aggressive questioning is a tradition that dates back decades.But Trump appeared eager to advance an argument about White House press corps "decorum," no matter how hypocritical.Since the judge criticized the government for not following due process before banning Acosta on November 7, the letter looked like an effort to establish a paper trail that could empower the administration to boot Acosta again at the end of the month.The letter gave Acosta less than 48 hours to contest the "preliminary decision" and said a "final determination" would be made by Monday at 3 p.m.CNN's lawyers had signaled a willingness to settle after prevailing in court on Friday. Ted Boutrous, an attorney representing CNN and Acosta, said they would welcome "a resolution that makes the most sense so everyone can get out of court and get back to their work."But in a new court filing on Monday morning, CNN's lawyers said the defendants "did not respond to this offer to cooperate." Instead, the letter from Shine and Sanders was an "attempt to provide retroactive due process," the filing alleged.So CNN and Acosta asked the judge to set a schedule of deadlines for motions and hearings that would give the network the chance to win a preliminary injunction, a longer form of court-ordered protection to Acosta's press pass.They were seeking a hearing "for the week of November 26, 2018, or as soon thereafter as possible," according to the court filing.A preliminary injunction could be in effect for much longer than the temporary restraining order, thereby protecting Acosta's access to the White House.In a response Monday morning, government lawyers called the CNN motion a "self-styled 'emergency'" and sought to portray the White House's moves as a lawful next step."Far from constituting an 'emergency,' the White House's initiation of a process to consider suspending Mr. Acosta's hard pass is something this Court's Order anticipated," they said.The DOJ lawyers continued to say that the White House had made "no final determination" on Acosta's access, and asked the court to extend its own deadline, set last week, for a status report due at 3 p.m. Monday, in light of the White House's separate self-imposed deadline for the Acosta decision.At lunchtime, Kelly granted the government's request and extended the status report deadline to 6 p.m. Monday.The case was assigned to Judge Kelly when CNN filed suit last Tuesday. Kelly was appointed to the bench by Trump last year, and confirmed with bipartisan support in the Senate. He heard oral arguments on Wednesday and granted CNN's request for a temporary restraining order on Friday."We are disappointed with the district court's decision," the Justice Department said in response at the time. "The President has broad authority to regulate access to the White House, including to ensure fair and orderly White House events and press conferences. We look forward to continuing to defend the White House's lawful actions."Trump seemed to shrug off the loss, telling Fox's Chris Wallace in an interview that "it's not a big deal."He said the White House would "create rules and regulations for conduct" so that the administration can revoke press passes in the future."If he misbehaves," Trump said, apparently referring to Acosta, "we'll throw him out or we'll stop the news conference.""This is a high-risk confrontation for both sides," Mike Allen of Axios wrote in a Monday item about Trump's new targeting of Acosta. "It turns out that press access to the White House is grounded very much in tradition rather than in plain-letter law. So a court fight could result in a precedent that curtails freedom to cover the most powerful official in the world from the literal front row."The-CNN-Wire 5546

The United States of America will NOT be cutting funding to @starsandstripes magazine under my watch. It will continue to be a wonderful source of information to our Great Military!— Donald J. Trump (@realDonaldTrump) September 4, 2020 243

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

The Trump administration plans to raise pending tariffs on 0 billion in Chinese goods to 25% from 10%, a source familiar with discussions confirmed to CNN.The news was first reported by Bloomberg.The move, which is not finalized and could change, according to the source, comes as the United States and China remain locked in a trade war. Talks between US and Chinese officials have done little to ease tensions.The United States has already imposed 25% tariffs on Chinese goods worth billion. China immediately responded with its own tariffs on US goods worth billion.A second round of tariffs on products worth billion could take effect as soon as this week.US Trade Representative Robert Lighthizer earlier this month ratcheted up tensions when he released a list of thousands of additional Chinese exports worth 0 billion that could face 10% tariffs after a public comment period. It included fruit and vegetables, handbags, refrigerators, rain jackets and baseball gloves.Those tariffs, which might now be steeper, could go into effect as soon as September. 1108