Food and Drug Administration

Sept. 4 (UPI) — The Food and Drug Administration on Friday approved a new, targeted breast cancer drug for patients who become resistant to hormone therapy.

The drug, camizestrant, was approved under the FDA’s accelerated approval program.

It acts on ESR1 mutations, which are acquired resistances that tumors may develop during treatment for metastatic breast cancer.

“Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment,” acting FDA Commissioner Kyle Diamantas said in a statement. “We owe them every weapon in our arsenal.”

“Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”

Dr. Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said, “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval.”

“This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show that the disease is progressing,” he added.

“But additional evidence is needed to confirm clinical benefit.”

Sept. 3 (UPI) — The U.S. Food and Drug Administration on Thursday issued an Emergency Use Authorization for two drugs to prevent and treat New World screwworm, or NWS, in dogs and cats.

According to the agency, Capstar tablets and their generic version, nitenpyram, are approved for dogs, puppies, cats and kittens that are at least 4 weeks old and weigh at least 2 pounds.

Nitenpyram tablets were approved for treatment in June.

“Although the FDA has authorized or conditionally approved multiple products for the treatment of New World screwworm in dogs and cats, none were for prevention – until today,” Timothy Schell, director of the FDA’s Center for Veterinary Medicine, said. “The FDA is addressing a previously unmet need and giving pet owners and veterinarians important tools to protect dogs and cats from NWS infestations.”

The U.S. Department of Agriculture has confirmed 48 domestic cases of NWS in animals as of Thursday.

The FDA said most dogs and cats in the United States are at low risk of exposure to NWS because confirmed cases “are in a limited geographic region.” It said that dogs and cats that live, travel to, or return from areas where NWS have been identified, should be watched closely for signs of infestations.

Signs of infestations include visible maggots, foul odors in sounds or body openings. Veterinary care should be sought immediately for infested dogs and cats, the FDA said.

Capster is produced by Indianapolis-based Elanco Animal Health, while nitenpyram is made by Dublin-headquartered Felix Pharmaceuticals.

Sept. 2 (UPI) — A group of medical organizations has released guidance on fall vaccinations against respiratory illnesses.

The Centers for Disease Control and Prevention usually launches a fall campaign to recommend seasonal vaccines for diseases like RSV, influenza and COVID-19. This year, however, the agency has not issued its updated recommendations for the respiratory virus season.

In March, the American Academy of Pediatrics won a lawsuit against the federal government that blocked Health and Human Services Secretary Robert F. Kennedy Jr. from overhauling the childhood vaccine schedule.

Kennedy and President Donald Trump have said that children get too many vaccines and have reduced the number of vaccines routinely recommended. They have also linked vaccines to autism, which has been proven untrue by research.

In response, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the Infectious Diseases Society of America each issued guidelines for fall immunizations. They based those guidelines on research from the American Medical Association and the University of Minnesota’s Vaccine Integrity Project

Last year, the CDC changed the COVID-19 recommendations to say that patients should talk to their own doctors.

On Tuesday, the agency said, “the CDC states the recommendations for seasonal influenza vaccination from the July 2025 immunization schedule remain in effect for the 2026-2027 influenza season.” It doesn’t mention the new mRNA flu vaccine, approved by the U.S. Food and Drug Administration last month.

“For more than 60 years, the United States has benefited from an established federal process for evaluating vaccine evidence and translating that science into recommendations for the American public. At the center of that process were the Centers for Disease Control and its Advisory Committee on Immunization Practices, the ACIP,” CNN reported Dr. Bruce Gellin, board chair of the Vaccine Integrity Project and professor of medicine at Georgetown University, said at a press briefing.

“Unfortunately today, the federal government is not fulfilling that responsibility in the way that it historically has. But the need for that work has not disappeared. Influenza, SARS-CoV-2 [COVID-19] and the RSV viruses will circulate again this fall and winter,” Gellin said.

“We cannot allow the breakdown of a federal process to create a vacuum in evidence-based vaccine guidance,” he added.

Dr. Sarah Nosal, president of the American Academy of Family Physicians, said in the news briefing that insurance companies have indicated they will cover the vaccines.

“Vaccines are one of medicine’s greatest success stories. They prevent serious illness, reduce hospitalizations and long-term complications and save lives,” Nosal said in a press release. “As federal guidance evolves, the science behind vaccines remains strong. These recommendations are grounded in the latest evidence, informed by public health experts and shaped by what family physicians are seeing every day in their patients.”

Aug. 27 (UPI) — The Food and Drug Administration on Thursday issued an emergency approval for the use of the drug ivermectin against New World screwworm infestations in cattle, adding to the arsenal of weapons available against the flesh-eating insect.

The FDA approved an Emergency Use Authorization, or EUA, for Bimectin, the generic version of ivermectin, for injections in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wounds, the agency announced.

Bimectin injection remains unauthorized for use in lactating dairy cows or in calves that will be processed for veal.

Thursday’s move is the 14th EUA issued by the FDA against New World screwworm as the Trump administration attempts to deal with the still-growing infestation in Texas.

The Department of Agriculture has confirmed 47 domestic cases of New World screwworm, or NWS, in animals as of Thursday.

NWS is widely feared as a serious health and economic threat that could cost billions of dollars in losses to cattle, bison and horses. The pest was eradicated from the United States in 1966 and eliminated as far south as Panama by 2000, but reemerged in 2022 and has continued moving north through Central America and Mexico.

The U.S.-Mexico border was closed last year to protect U.S. animals from the threat. The ban was subsequently lifted on July 26.

Texas Agriculture Commissioner Sid Miller last month urged the FDA to authorize ivermectin in feed as an additional tool to combat the growing NWS threat.

Injectable ivermectin is not enough to keep pace with the outbreak and protect livestock from further infestations, he asserted.

“Texas ranchers are fighting for their livelihoods and the security of the American food supply. They don’t have time to wait,” Miller said. “We’ve already seen this parasite spread across multiple Texas counties in just a few weeks. Every day we delay is another day the New World screwworm gains ground. We need every effective weapon available, and we need it now.”

The Texas Grain and Feed Association “has committed to rapidly manufacture and distribute medicated feed upon approval, ensuring producers can begin using it without delay,” he noted.

Aug. 26 (UPI) — On Wednesday, the U.S. Food and Drug Administration announced its approval of Rasonque, a new treatment option for people with advanced pancreatic cancer.

A tablet taken once a day, the medication targets forms of a protein called RAS, which is a key driver of tumor growth in many patients with pancreatic adenocarcinoma, the most common form of the cancer, the FDA said. This form of cancer develops in cells lining the ducts of the pancreas.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer,” said Kyle Diamantas, acting commissioner of the FDA. “It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible.”

A press release from the FDA said the approval demonstrates the agency’s “commitment to moving with urgency, reducing unnecessary delays and advancing innovative treatments.”

Rasonque has been approved for adults who have metastatic pancreatic adenocarcinoma who have received at one least one prior systemic therapy or those who are not candidates for multiagent systemic therapy.

About 90% to 95% of the new cases of pancreatic cancer diagnosed in the United States each year are this form, the FDA said, citing the National Cancer Institute. Johns Hopkins Medicine also said “the vast majority” of pancreatic cancer diagnoses are this form.

In a clinical trial, the new treatment improved median overall survival to 13.2 months from 6.7 months with standard chemotherapy, the FDA said.

“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, director of the FDA’s Oncology Center of Excellence.

The agency granted this approval to Revolution Medicines Inc.

Aug. 25 (UPI) — On Tuesday, the U.S. Food and Drug Administration approved a device designed to continuously monitor both blood sugar levels and ketone levels in people with diabetes.

The Libre Duo 10-Day Continuous Dual Glucose Ketone Monitoring System is the first of its kind to be approved in the United States — both the first wearable device to monitor ketone levels and the first to combine monitoring of ketone and blood sugar levels, the FDA said. It’s approved for those ages 2 and older.

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”

The U.S. Centers for Disease Control and Prevention estimates that 40.1 million Americans live with diabetes. About 2.1 million of them have type 1 diabetes, which also makes it important to monitor the levels of ketone, an acid. The body creates this substance when, due to a lack of insulin, it uses fat instead of glucose to produce energy. Too much ketone can cause diabetic ketoacidosis, a dangerous complication.

“Early detection of rising ketone levels is critical,” the FDA said.

Until now, the agency said, people had to monitor ketone levels with separate tests that only provided a single measurement at one point in time. The new system combines blood sugar and ketone tests and monitors them continuously. Readings — and alerts in case of dangerous trends — are sent wirelessly to a smartphone app.

The FDA previously granted “breakthrough device” status to the system, which is meant to expedite the device’s development and review.

Aug. 20 (UPI) — President Donald Trump has nominated White House aide Dr. Heidi Overton to lead the Food and Drug Administration, drawing anger from Democrats and criticism from a key Republican senator.

Trump announced his nomination of Overton to be the next FDA commissioner on his Truth Social platform Wednesday, calling the deputy director of the White House Domestic Policy Council “a ROCKSTAR in my administration.”

“She is known to take on the HARDEST issues, and bring me solutions that work best for the Country,” Trump said. “We need her leadership at the FDA now to ensure that the U.S. remains the WORLD LEADER for Scientific Discovery and CURES.”

If confirmed by the Senate, Overton will be tasked with overseeing agency policy concerning drugs, vaccines, tobacco products and much of the food supply, among other responsibilities. Kyle Diamantas, a friend of Trump’s son Donald Trump Jr. has been serving as acting FDA commissioner since Marty Makary resigned as head of the agency in May following reported clashes with the Trump administration over its decision to authorize fruit-flavored electronic cigarettes.

“Heidi brings exceptional judgment, professionalism, discipline and an unwavering commitment to the American people,” Department of Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement supporting her nomination to lead the FDA under him.

“I have seen her challenge assumptions, demand excellence and turn bold ideas into meaningful results.”

She has had an increasingly visible presence near the president in recent months and most recently appeared with him earlier this month when he signed an executive order to reduce the number of vaccines recommended for children, which has sparked widespread concern among the medical community.

House Speaker Mike Johnson, R-La., called Overton “a woman of deep faith, an accomplished physician and a champion of the America First agenda” as he congratulated her on the nomination.

“I have seen firsthand her ability to navigate complex policy challenges with conviction and clarity,” he said in a social media statement.

“She will serve our country well.”

While Republicans praised Trump’ pick, Sen. Bill Cassidy, a doctor, broke ranks, saying that while he respected her experience as a physician, “I have strong concerns about her nomination,” citing her lack of managerial experience of a large organization, such as the FDA, which is dealing with staffing and morale issues.

“Additionally, Dr. Overton’s active role in last week’s nonsensical vaccine executive order calls into question her commitment to standing up for sound science and protecting children’s health,” he said online.

“That alone is almost disqualifying.”

Cassidy, who represents Louisiana, will play a key roe in her confirmation as chairman of the Senate Health, Education Labor and Pensions Committee a key vote in whether she is confirmed. Republicans can afford to lose only three votes on the Senate floor, as they only hold a 53-seat majority. The two independent senators caucus with the Democrats, who are all expected to all vote against her nomination.

“Heidi Overton is a far-right, anti-abortion extremist who has no business leading the FDA,” Sen. Patty Murray, D-Wash., said in a statement.

“The American people deserve someone who will put science and facts FIRST, not another Trump sycophant who will make it their mission to attack medication abortion.

“I will vote NO.”

Reproductive health organizations also criticized Trump’s pick, pointing to Overton’s celebration of the overturning of Roe vs. Wade, returning oversight of abortion to the states, as a “huge victory” and to her advocacy for what they described as the politicization of government agencies when she worked at the far-right America First Policy Institute think tank.

“Donald Trump is trying to put an anti-abortion extremist in charge of any agency that could seriously undermine reproductive healthcare — including the agency that could roll back access to mifepristone nationwide,” Reproductive Freedom for All President and CEO Mini Timmaraju said in a statement, referring to a prescription oral medication used to terminate an early pregnancy.

“Her nomination is another alarming step in Trump’s plan to weaponize every part of the federal government to restrict abortion nationwide.”

Aug. 19 (UPI) — President Donald Trump is expected to nominate Dr. Heidi Overton, a White House policy aide, to lead the Food and Drug Administration.

The decision was reported by the Washington Post, The New York Times and Politico, all citing anonymous sources. Overton is an aide at the White House’s Domestic Policy Council and will be tapped to be the next FDA commissioner, sources say.

Overton will replace Marty Makary, who left the position in May, and the Senate will have to confirm her to the position.

The FDA commissioner is one of the most powerful jobs in U.S. health care. The FDA oversees drugs, vaccines, tobacco products, the bulk of the food supply and more. The position has remained open longer than expected as some have turned it down over fears of administration interference, the Post reported.

The position has been run by acting FDA Commissioner Kyle Diamantas, a friend of Donald Trump Jr., and a former partner at the law firm Jones Day.

Overton is board-certified in public health and general preventive medicine and was a general surgery resident at Johns Hopkins Hospital in Baltimore, where she also earned a doctorate in clinical investigation. She worked at the America First Policy Institute, a conservative think tank. She has also written articles calling abortion “corrosive” to women. She called abortion pills “far more dangerous to women” and has called for more controls on the pills.

In September, Secretary of Health and Human Services Robert F. Kennedy Jr. said Overton and Calley Means worked on a Make America Healthy Again strategy report calling for more review of chemicals in food and an increase in oversight over pharmaceutical advertisements, The Times reported.

Makary left the position in May because he disagreed with the administration’s policy of allowing tobacco and e-cigarette companies to sell flavored vapes. The White House had been pressuring Makary to allow the vapes, but he disagreed, citing their appeal to teens and young adults.

The FDA approved mango and blueberry vapes just after Trump had lunch with tobacco executives, The Times reported.

While she is a doctor and has been present for many FDA announcements at the White House, she hasn’t run a large agency before. The FDA has thousands of employees and shapes food safety and pharmaceutical policies.