A blast of the season’s first frigid air was bearing down on much of the U.S., bringing the prospect of snow to parts of the country and plunging temperatures in Florida — though it may not get cold enough there for iguanas to tumble from the treetops. National Weather Service forecasters said frigid Arctic air will pour into the eastern two-thirds of the country on Monday, bringing with it the chance for record temperatures in the U.S. Southeast. That includes all of Florida, where temperatures in parts of the state were near 80 degrees Fahrenheit just a day ago.
The U.S. Food and Drug Administration said on Monday (November 10) it would remove the strictest "black box" warnings from hormone therapies used to treat menopause symptoms, a move that may boost access to treatments long shunned by patients and doctors over safety fears.
FDA Commissioner Marty Makary said the decision follows an extensive review of scientific literature, input from an expert panel in July, and a public comment period.
The agency is also approving two new drugs for the treatment of menopausal symptoms, he said, including a generic version of Pfizer's Premarin and a non-hormonal treatment for moderate to severe vasomotor symptoms, such as hot flashes, associated with menopause.
The agency said it was working with drug manufacturers to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.
Hormone replacement therapy, or HRT, was widely prescribed, including to protect women from chronic diseases, especially heart disease, for decades. But its use plunged after a 2002 Women's Health Initiative study found it could raise the risk not only of breast and ovarian cancer but also of strokes and other serious conditions.
The American College of Obstetricians and Gynecologists welcomed the move, which it said it had long advocated for.
The move was also welcomed by Claire Gill, founder and president of the National Menopause Foundation, who called it an important first step in addressing access to therapies for women suffering from menopausal symptoms.
Makary said drugmakers welcomed the move. "The companies are, generally speaking, very excited when the FDA tells them you can remove a scary warning on your product," he said.
Digital health firms, including Hims & Hers Health, WeightWatchers International and Noom, have rolled out programs designed to support women experiencing a shift in hormone levels during menopause, citing a link between the cessation of menstrual cycles and weight gain.
Hims in an October announcement said the offering would help drive the company toward $1 billion in yearly revenue by 2026.
Hormone replacement therapy for menopause replenishes the hormones, primarily estrogen, that decline with menopause to relieve symptoms like hot flashes and vaginal dryness.
All menopause treatments containing estrogen carry a warning that it increases the risk of strokes, blood clots and perhaps dementia. It also warns of the possibility of breast cancer.
A black box warning is the most severe the FDA can place for a prescription medication, indicating serious or potentially fatal side effects.
Josh Hammer breaks down the shifting landscape in Washington as the government shutdown nears its end after a pivotal Senate test vote. He exposes why Democrats are fighting tooth and nail to preserve Obamacare subsidies—and what their stance reveals about the party’s real agenda.
Josh then tackles the disturbing spectacle of President Trump being booed at an NFL game during a military swearing-in ceremony, calling it a sign of how far America’s cultural respect has eroded.
He closes the show with filmmaker Robby Starbuck, diving into the collapse of the woke era and Starbuck’s battle against corporate discrimination and ideological targeting across America.
President Trump joined the NFL on Fox crew during the Detroit Lions and Washington Commanders game. The President called a few plays and even help broadcast a touchdown call!
The Supreme Court has temporarily blocked full funding of SNAP food aid payments amid the ongoing government shutdown.
In an emergency order, the high court allowed the Trump administration to partially fund SNAP benefits for November, overriding a lower court ruling that had required full funding.
The administration had argued that a contingency fund did not have enough money to cover the full payments.
As a result, federal food aid to tens of millions of Americans has been reduced while the government remains partially shut down.
President Donald Trump has issued pardons for several of his allies accused of attempting to overturn the 2020 election, a Justice Department official said.
Those pardoned include his former personal attorney Rudy Giuliani, former chief of staff Mark Meadows, and conservative lawyers Sidney Powell and John Eastman.
The Justice Department’s pardon office posted the signed proclamation online, granting each a full, complete, and unconditional pardon.
The document makes clear the pardons do not apply to Trump himself. None of the individuals had been charged with a federal crime.
The Senate took its first step Sunday toward ending the historic government shutdown that has now lasted more than a month.
Moderate Democrats agreed to advance a compromise bill without a guaranteed extension of health care subsidies, a move that drew criticism from some within their party.
The legislation would fund the government and set up a mid-December vote on whether to extend expiring health care tax credits.
Senate Democratic Leader Chuck Schumer of New York voted against the measure. Final passage could still take several days if Democrats seek to delay the process.
In a time when political establishments, globalist bureaucracies, and >>In a time when political establishments, globalist bureaucracies, and multinational corporations dominate so much of life, Alex Marlow offers a strong and independent voice. <<
Jennings is battle-tested on cable news, a veteran of four presidential >>Jennings is battle-tested on cable news, a veteran of four presidential campaigns, and a former Special Assistant to President George W. Bush. Now, he’s on a mission to arm listeners with common sense, crush liberal narratives, and help shape the . . . . <<
Hugh Hewitt is one of the nation’s leading bloggers and a genuine media >>Hugh Hewitt is one of the nation’s leading bloggers and a genuine media revolutionary. He brings that expertise, his wit and what The New Yorker magazine calls his “amiable but relentless manner” to his nationally syndicated show . . . . <<
Larry Elder personifies the phrase “We’ve Got a Country to Save” The “Sage from >>Larry Elder personifies the phrase “We’ve Got a Country to Save” The “Sage from South Central” is back on the radio and TV! <<
Salem Media, our partners, and affiliates use cookies and similar technologies to enhance your browsing experience, analyze site traffic, personalize site content, and deliver relevant video recommendations. By using this website and continuing to navigate, you consent to our use of such technologies and the sharing of video viewing activity with third-party partners in accordance with the Video Privacy Protection Act and other privacy laws.Privacy Policy