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Trudhesa (generic name: dihydroergotamine mesylate) will be dispensed with a prescription through Trudhesa Direct, a pharmacy partnership and copay program that will deliver the medication to patients’ homes at no additional cost. “We are delighted with the approval of Trudhesa and are proud to offer the millions of Americans with migraine a non-oral, acute treatment option that may provide rapid, sustained, and consistent relief, even when taken late into a migraine attack,” Adrian Adams, chairman and chief executive officer of Impel NeuroPharma, said in a press release....

On Wednesday, the federal agency announced that it would authorize the use of Pfizer’s pill, Paxlovid, for the treatment of mild and moderate cases of COVID-19 in high-risk individuals who are more likely to be hospitalized or die from the virus. “Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” director of FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, said in a statement....

Potentially unsafe drugs arrive in the U.S. each day. It’s happening because overseas drugmakers simply face far less scrutiny than domestic U.S. drug manufacturers. The FDA frequently issues “warning letters” to these overseas factories for these safety violations. But nothing gets fixed. Consider this: Americans take an estimated 131 million prescription drugs each day. And 90 percent of these prescriptions are filled by generic medications. The United States is now reliant on imports for at least two-thirds of these generic drug needs....

While the FDA’s investigation is ongoing, the agency said that the outbreak had been traced back to red, white, and yellow onions that were distributed by Idaho-based ProSource Produce. The onions in question were reportedly imported from Chihuahua, Mexico, from July 1 to August 27. ProSource has agreed to recall onions that it had imported from those dates, the FDA said. These onions were then sold to various retailers across the country, including restaurants, grocery stores, and fresh markets, allowing the tainted produce to make its way to consumers’ homes and businesses....

What transpired in American history and culture to turn the first girl into the second is the subject of Joan Jacobs Brumberg’s fascinat- ing and important new book, The Body Project (Random House. $25), which tracks girls and their bodies from the era of repression to the cul- ture of obsession. ““Before the twentieth century, girls simply did not organize their think- ing about themselves around their bodies,’’ she writes....

The move will be done in collaboration with the United States, and as part of a large 10-year investment into the country’s defense capabilities, the Associated Press reported. The decision comes amid growing unease in the Pacific regarding Chinese aggression and militarism, which Australian Prime Minister Scott Morrison likened on Wednesday to a “changing global environment.” “Creating our own sovereign capability on Australian soil is essential to keep Australians safe,” Morrison said in an announcement....

Standing across from the New York Stock Exchange, the statue debuted a white lace collar in homage to Ginsburg’s instantly recognizable fashion piece. The bold new look also appeared in a full-page New York Times ad from State Street Advisors, below the line, “Here’s to the original.” Since Fearless Girl was unveiled in New York in 2017, it has become a powerful monument to female empowerment. The clever connection to Ginsburg is no accident, with the powerhouse Supreme Court justice known for a career dedicated to championing women’s rights and eliminating gender-based discrimination....

Fear of an imminent bloodbath has seized Burundi. The tiny central African nation contains the same combustible mix of Hutus and Tutsis as neighboring Rwanda; tribal violence there last year cost a million lives and displaced as many as 3 million people. Poor. largely agricultural and desperately overcrowed, Burundi has been in almost constant turmoil since the country’s first democratically elected president, Melchior Ndadye, a Hutu, was gunned down in an attempted military coup by Tutsi hard-liners in October 1993....

Followers of the radical movement, which is listed as a domestic terrorist threat by the FBI, were part of the mob of extremists who stormed Congress on Wednesday in what lawmakers described as an attempted coup incited by President Donald Trump. In the days since the violence that left five people dead, including a police officer, some high-profile followers of the QAnon conspiracy theory have said the military should be brought in to stop Joe Biden entering the White House or claimed that Trump will somehow remain president....

Big Al, as the creature is known, would be a victim of “culling,” a practice in Australia that allows people to shoot the kangaroos in order to control their population size. The culls reportedly help protect grasslands and the population sizes of other creatures, like lizards. Yahoo News Australia reported that on Tuesday morning, flyers were distributed warning residents of the area to stay away, as a kangaroo cull would be underway that night....

U.S. Magistrate Judge David Peebles ruled last week that Fine’s wife, Laurie Fine, is entitled to some documents from 2005 for her libel suit against ESPN. The university had claimed it could withhold the documents because they were their lawyers’ work in anticipation of a possible lawsuit. Peebles reviewed the records and determined they were prepared during the ordinary course of business. Unless the university appeals, Peebles said it has to produce the documents within three weeks....

U.S. District Judge Michael Simon issued a temporary restraining order that will prevent the Trump administration’s rule, which was set to take effect Sunday. A lawsuit was filed Wednesday by seven American citizens and a nonprofit group who all contended the rule would prevent about two-thirds of prospective legal immigrants, the Associated Press reported. The lawsuit furthermore states the Trump rule could potentially eliminate or reduce the amount of immigrants with family-sponsored visas....

In denying the vast majority of the school’s motions to dismiss cases, U.S. District Judge Aleta Trauger brings the question of whether the university will pursue a settlement in the case. MORE: Less talk, swift action needed | Jones: No culture problem at UT Eight women, identified only as Jane Does, sued the university in February, alleging a pattern and practice of deliberate indifference to sexual assaults and misconduct by Tennessee athletes....

The decision was made on the grounds that the sailors defied the vaccination mandate on religious grounds. These sailors are part of the very few sailors that have not been vaccinated, as at least 98.5 percent of active and reserve Navy members have been vaccinated. The ruling is a blow to Secretary of Defense Lloyd Austin’s push to make vaccines mandatory for all branches of the military. “The Navy servicemembers in this case seek to vindicate the very freedoms they have sacrificed so much to protect,” wrote U....

The Swiss 17-time major winner claimed his 23rd ATP World Tour Masters-level tournament with a straight-sets win in the final over France’s Gilles Simon on Sunday. Rafael Nadal slipped to third as a result of Federer’s win, and the Spaniard’s own failure to surpass the second round, where he was beaten by countryman Feliciano Lopez. Nadal, a 14-time major champion, was suffering appendicitis in China, and could not defend his points gained 12 months earlier when he reached the semifinals at the ATP 1000 event....

Federer is into the semifinals in Istanbul, an ATP 250 event played on clay courts that he is expected to win. Madrid shapes as a much bigger test in what is the second-last Masters event before the French Open later in May. Federer, the top seed, gets a first-round bye before a potential meeting with Australian Nick Kyrgios. The Aussie is in his second tournament back from an ankle injury and has surged into the last four in Estoril....

Sexual dysfunction refers to a problem during any part of sexual activity, from arousal to orgasm. Physical factors such as illnesses, surgeries, and hormonal changes related to menopause are often implicated in female sexual dysfunction, along with psychological factors like depression, anxiety, stress, and relationship difficulties. Here are some of the most common physical and psychological factors that may contribute to challenges enjoying sex. Physical Factors Hysterectomy Hysterectomy is the most common gynecological surgery, and about 20% of women report a decline in sexual function post-operatively....

City finished 2017 with three games in eight days, the final clash against Crystal Palace on Sunday bringing their winning streak to a halt at 18 matches. The league leaders were far from their fluent best in the 0-0 draw at Selhurst Park, while star players Gabriel Jesus and Kevin De Bruyne picked up injuries, leading Guardiola to plead for referees to protect players . There will be no let-up in the schedule for Guardiola’s men with the visit of Watford on Tuesday before cup clashes with Burnley and Bristol City to complete six games in 18 days over Christmas and new year....