MATTHEW PERRONE Health Writer, Author at The Rapid City Post

Hims & Hers launches copy of Wegovy pill, prompting legal threats from drugmaker Novo Nordisk

February 5, 2026

Telehealth company Hims & Hers is launching a cheaper, off-brand version of the blockbuster weight loss pill Wegovy. The news comes just weeks after the drug’s original manufacturer launched the reformulated drug, which was previously only available as an injection. The announcement from Hims is the latest example of the company’s efforts to capitalize on obesity drugs like Wegovy, which have shown dramatic success in helping users shed pounds. Novo Nordisk said Thursday it will take legal action against the new pill, which it called unapproved and inauthentic. Hims’ new drug is a compounded medication, which means it is not subject to most federal drug regulations.

Dr. Marty Makary, commissioner of the Food and Drug Administration speaks at an event on addiction recovery in the Oval Office of the White House, Thursday, Jan. 29, 2026, in Washington, as Attorney General Pam Bondi and Interior Secretary Doug Burgum listen. (AP Photo/Allison Robbert)

House lawmaker raises new concerns over FDA’s ultra-fast drug review program

February 3, 2026

A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs. The initiative by FDA Commissioner Marty Makary promises ultra-fast reviews for drugs that align with “national priorities.” But the effort has become a flashpoint for controversy outside and inside the agency. Rep. Jake Auchincloss of Massachusetts sent a letter Tuesday questioning the legal underpinning of the program and asserting that the agency isn’t following federal disclosure requirements. Specifically, Auchincloss says the agency has failed to file financial disclosure forms for eight senior FDA officials involved in the program.

FILE - The Altria Group Inc. corporate headquarters are seen in Richmond, Va., April 23, 2008. (AP Photo/Steve Helber, File)

Altria earnings fall short amid lower cigarette sales and competition for nicotine products

January 29, 2026

Shares of Altria dipped Thursday after the tobacco giant reported flat earnings due to declining cigarettes sales and challenging competition for newer products, including flavored nicotine pouches. The Richmond, Virginia-based company said fourth-quarter revenue slid 2% to $5.8 billion, mainly driven by lower cigarette sales. Tobacco companies have long had to manage shrinking sales of their main product category, but Altria executives said cigarettes have been increasingly squeezed by the introduction of unauthorized disposable electronic cigarettes, which are often cheaper and come in fruit and candy flavors.

FILE - Containers of Zyn, a smokeless nicotine pouch, are displayed for sale among other nicotine and tobacco products at a newsstand on Feb. 23, 2024, in New York. (AP Photo/Bebeto Matthews, File)

What to know about FDA’s review of new Zyn advertising proposal

January 22, 2026

The Food and Drug Administration is weighing whether to allow new advertising messages about Zyn, a type of nicotine pouch that’s growing in popularity. Agency advisers are holding an all-day meeting Thursday to consider a request from Philip Morris to begin promoting Zyn as a less-harmful alternative for adult smokers. Studies submitted by the company suggest that switching to Zyn can lower the risks of lung cancer, stroke and other smoking-related ailments. But the FDA and its advisers must weigh those benefits against other potential risks, including use by underage teenagers.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

January 16, 2026

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times. The initiative by FDA Commissioner Marty Makary promises ultra-fast reviews for drugs that align with “U.S. national priorities.” It’s at the center of Makary’s stated goal to “cut red tape” and “challenge assumptions” at the agency tasked with assuring the safety of food, medicines, medical devices and other consumer goods. But FDA staffers tell The Associated Press the push for faster approvals is contributing to a climate of anxiety, fear and confusion within the agency’s drug center.

Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks during a press briefing at the White House, Wednesday, Jan. 7, 2026, in Washington. (AP Photo/Jacquelyn Martin)

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

January 16, 2026

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that’s been rocked by recent layoffs and resignations. Agency staffers and outside experts worry the FDA commissioner’s voucher program runs afoul of legal, ethical and scientific standards used to review new medicines. FDA staffers tell The Associated Press the effort is taking decisions away from career scientists and placing them in the hands of political appointees. The program awards vouchers to drugs favored by President Donald Trump’s administration, promising reviews in as little as one month, not six to 10 months. Health and Human Services says the voucher program prioritizes “gold standard scientific review.”

At-home STD tests offer new options for screening and treatment

January 12, 2026

New options for testing and treating some of the most common sexually transmitted diseases are becoming available. In the past year, U.S. health officials approved new home-based tests that can detect common infections like gonorrhea, chlamydia and HPV. The Food and Drug Administration also approved two new drugs for gonorrhea, the first new options in decades. Experts hope the trend toward access and convenience will keep downward pressure on infection rates. Cases of sexually transmitted diseases have been falling for several years after spiking during the COVID-19 pandemic.

FILE - In this Aug. 18, 2015 file photo, Sprout Pharmaceuticals CEO Cindy Whitehead holds a bottle for the female sex-drive drug Addyi in Raleigh, N.C. (AP Photo/Allen G. Breed, File)

FDA OKs libido-boosting pill for women who have gone through menopause

December 15, 2025

U.S. health officials have expanded approval of a drug that boosts libido in women who report stress due to a low sex drive. The drug from Sprout Pharmaceuticals is now approved for women older than 65 who have gone through menopause. Previously, the once-a-day pill was only for premenopausal women. The drug has not been a big seller, despite its status as the first drug approved for a sexual disorder in women. Warnings on the drug alert doctors and patients that drinking alcohol in combination with it can cause fainting and low blood pressure. Raleigh, North Carolina-based Sprout says the approval reflects years of work with the FDA to change “how women’s sexual health is understood.”

FILE - The U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md., Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File)

FDA opens safety review of injectable RSV drugs approved for babies and toddlers

December 9, 2025

Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV virus. The drugs from Merck and Sanofi are not vaccines. But officials under Health Secretary Robert F. Kennedy Jr. have recently been scrutinizing a number of childhood shots. A spokesperson for Kennedy said the FDA will evaluate the latest data and consider updating labeling on the drugs. RSV typically causes mild symptoms in healthy adults, but it can be life-threatening for the very young and old. In recent years, federal advisers have recommended the RSV shots for babies and toddlers facing their first RSV season.

New FDA-approved glasses can slow nearsightedness in kids

November 30, 2025

A new type of lens approved by the FDA promises to slow nearsightedness in children. These specialized glasses, available in the U.S. for the first time, aim to reduce the progression of myopia in kids aged 6 to 12. The lenses use concentric rings to refocus light, potentially preventing severe eye issues like cataracts and retinal detachment. Retailing for $450, they are expected to be covered by major U.S. vision insurance providers. Experts believe the glasses offer a preferable alternative to contact lenses for young children.

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

November 14, 2025

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year. Sarepta Therapeutics’ Elevidys will carry the FDA’s strongest warning label about the risks of liver damage and liver failure, the agency said Friday. The action follows months of scrutiny surrounding Elevidys after two teenage boys died after taking the one-time treatment. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy, the fatal muscle-wasting disease that affects males. The FDA also said it will limit the treatment to patients who can still walk.

In this image taken from video, an IV infusion is administered at Pure Alchemy Wellness, Tuesday, Nov. 11, 2025, in Chula Vista, Calif. (AP Photo/Javier Arciga)

A closer look at the unapproved peptide injections promoted by influencers and celebrities

November 13, 2025

Unapproved peptide drugs have become a trendy new approach to building muscle, smoothing wrinkles and trying to live longer. But many of the products sold online haven’t been studied in humans and aren’t FDA approved. Behind the trend is the blockbuster popularity of GLP-1 weight loss medications, which have been proven to help users rapidly lose weight. But influencers, wellness gurus and celebrities are now promoting many more obscure peptides for alternative uses. Here’s a closer look at the science, the hype and the potential risks surrounding this wellness trend.

FDA names longtime cancer scientist Pazdur to lead drug center

November 11, 2025

The Food and Drug Administration has named a longtime regulator of cancer medications to lead the agency’s drug center. The announcement comes after the previous FDA official in the role was ousted following an ethics complaint. The FDA said Tuesday that Dr. Richard Pazdur will become director of the Center for Drug Evaluation and Research, the largest unit of the health agency. Pazdur previously served in various FDA roles, including leading the agency’s Oncology Center of Excellence. His predecessor in the job resigned early this month after a lawsuit alleging he used his role at the FDA to pursue a vendetta against a former business associate.

FDA Commissioner Martin Makary speaks during an event about drug prices with President Donald Trump, Thursday, Nov. 6, 2025, in the Oval Office of the White House in Washington. (AP Photo/Evan Vucci)

FDA will remove long-standing warning from hormone-based menopause drugs, citing benefits for women

November 10, 2025

The Food and Drug Administration says it will remove a long-standing warning from hormone-based drugs used to treat menopause symptoms in women. The change announced Monday is a break from more than 20 years of FDA policy, in which the drugs carried the agency’s most severe warning label. But FDA Commissioner Marty Makary and some other doctors have long criticized the current warning label as outdated and unnecessary. They say it discourages some women from seeking treatment that can help with hot flashes, vaginal dryness and other uncomfortable symptoms. Other experts have said the warning carries important information about risks of stroke, heart attack and breast cancer.

FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’

November 2, 2025

The head of the Food and Drug Administration’s drug center abruptly resigned Sunday amid concerns about his personal conduct. A federal spokesperson said Dr. George Tidmarsh left the agency after federal lawyers began looking into “serious concerns about his personal conduct,” according to an official statement. Tidmarsh had been serving as the FDA’s top regulator since July. His resignation came the same day that a drugmaker filed a lawsuit against him alleging “false and defamatory statements” about its products. The drugmaker, Aurinia Pharmaceuticals, is chaired by one of Tidmarsh’s former business associates.

FILE - A child shows off her teeth after a dental exam in Concord, N.H., Wednesday, Feb. 21, 2024. (AP Photo/Robert F. Bukaty, file)

FDA restricts use of kids’ fluoride supplements citing emerging health risks

October 31, 2025

The Food and Drug Administration is restricting the use of fluoride supplements used to strengthen children’s teeth. The agency said on Friday that the tablets and lozenges should only be used in children three and older who face serious risks of tooth decay. It’s the latest action by Health Secretary Robert F. Kennedy Jr. and his deputies against fluoride, a chemical that is a mainstay of dental care. The FDA stopped short of seeking to remove the products from the market, which it proposed in May. Instead, manufacturers have been warned not to market the products outside the new age limits.

Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks in the Oval Office of the White House during an event with President Donald Trump, Thursday, Oct. 16, 2025, in Washington. (AP Photo/Alex Brandon)

FDA unveils drugs to receive expedited review in support of ‘national priorities’

October 16, 2025

The Food and Drug Administration is announcing the first round of drugs that will receive drastically expedited reviews at the agency. It’s part of an effort by the Trump administration to prioritize medicines that are seen as supporting U.S. national interests. The nine drugs announced by the agency include a potential treatment for people undergoing infertility treatments. President Donald Trump has pledged to lower costs for those treatments since his days on the campaign trail. Until now, the fastest FDA reviews took at least six months. That’s for groundbreaking drugs to treat life-threatening diseases. Under the new initiative, the FDA is aiming to review the designated drugs in one or two months.

FDA approves another generic abortion pill, prompting outrage from conservatives

October 2, 2025

Federal health officials have approved another generic version of the abortion pill, prompting outrage from abortion opponents. Anti-abortion groups quickly criticized the move on Thursday, calling it a “stain” on the Trump administration. The groups have been pushing for a safety review of mifepristone for months. The FDA first approved the drug as safe and effective in 2000. The new version of the pill is from drugmaker Evita Solutions. It’s not the first generic version, which the FDA previously approved in 2019.

FILE - A marijuana plant is seen at a medical marijuana dispensary in Egg Harbor Township, N.J., March 22, 2019. (AP Photo/Julio Cortez, File)

A drug made from marijuana reduced back pain in a large study

September 29, 2025

A medication made from marijuana successfully reduced back pain in a new study. The results from a German drugmaker published Monday are the latest evidence that cannabis can be used to treat common forms of pain. The company plans to apply for approval in the European Union and eventually in the U.S. In the study of 800 patients, those receiving a liquid formulation of cannabis reported less pain, better sleep and improved physical function. Cannabis remains illegal under U.S. federal law, although most states have legalized the drug for either medical or recreational use. Many patients in state-sponsored medical marijuana programs report using the drug for pain, though quality research is limited.

FDA takes aim at Hims and other telehealth services in drug advertising blitz

September 16, 2025

The Trump administration has issued its first warnings to online services that offer unofficial versions of popular drugs like the blockbuster obesity treatment Wegovy. The Food and Drug Administration on Tuesday sent letters to Hims & Hers and dozens of other companies, ordering them to halt “false and misleading” statements about their medications. It’s the first time regulators have gone after online prescribing services, which don’t typically fall under FDA authority. The FDA says that Hims must drop language comparing its compounded drugs to brands like Wegovy, which are approved by the FDA.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File)

Trump’s plan for a drug advertising crackdown faces many hurdles

September 10, 2025

Health Secretary Robert F. Kennedy Jr. and other administration officials are vowing to crack down on deceptive drug ads, but they may encounter some major obstacles. President Donald Trump signed a memo Tuesday directing the FDA and other agencies to enforce transparency in pharmaceutical promotions. The FDA plans to issue warnings to drugmakers over misleading ads. However, the agency faces challenges, including legal pushback and staffing cuts. The administration also says it wants to reverse a 1997 rule allowing brief summaries of drug risks in TV ads, but that process could take years. The agency also has long struggled to police social media promotions.

FILE - This undated photo provided by the U.S. Centers for Disease Control and Prevention (CDC) shows a blacklegged tick, also known as a deer tick, a carrier of Lyme disease. (CDC via AP, File)

Unproven Lyme disease tests and treatments are proliferating

September 10, 2025

The complexity of diagnosing Lyme disease has given rise to an entire industry of unapproved tests and alternative treatments, including lasers, herbal remedies and electromagnets. There is no simple approach to diagnosing Lyme. Doctors have to use a combination of visual clues and information from their patient in combination with the standard medical test, which has a number of limitations. Lyme experts warn that patients may spend hundreds or thousands of dollars on bogus tests, which aren’t covered by insurance. Those results can lead to treatment with unapproved therapies that may do more harm than good.

In this photo provided by the Department of Health and Human Secretary, Robert F. Kennedy, Jr., right, conducts the swearing-in ceremony of Jim O'Neill as the Department's Deputy Secretary, June 9, 2025, in Washington. (Amy Rossetti/Department of Health and Human Services via AP)

Trump’s new CDC chief: A Washington health insider with a libertarian streak

August 29, 2025

President Donald Trump has picked a former investor and critic of health regulations to oversee the Centers for Disease Control and Prevention. Jim O’Neill currently serves as the health department’s number two official under health secretary Robert F. Kennedy Jr. His additional appointment comes after a tumultuous week at the CDC in which the agency’s director was forced out over disputes with Kennedy. A former associate of billionaire tech entrepreneur Peter Thiel, O’Neill previously helped run one of Thiel’s investment funds. He also previously served in government under George W. Bush, making him an outlier among Trump’s team of health outsiders.

FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

FDA’s new expert panels are rife with financial conflicts and fringe views

August 18, 2025

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products. The FDA has more than 30 panels of experts specializing in drugs, vaccines and other products. But increasingly, the agency isn’t calling them. Instead, FDA Commissioner Marty Makary is holding ad hoc sessions with outside experts who often have contrarian views and financial interests in the topics under discussion. The meetings have focused on issues of interest to Health Secretary Robert F. Kennedy Jr., including depression pills and talc powder.

U.S. Health Secretary Robert F. Kennedy Jr. attends a news conference, Tuesday, Aug. 5, 2025, in Anchorage, Alaska. (AP Photo/Mark Thiessen)

RFK Jr.’s vow to overhaul vaccine injury program echoes grievances of anti-vaccine movement

August 7, 2025

Health Secretary Robert F. Kennedy Jr. says he wants to rework the U.S. program for compensating Americans injured by vaccines. The plan has long been a target of anti-vaccine groups and changing it could have far-reaching consequences for vaccine availibility. Government officials set up the program in the 1980s to limit the legal risks for vaccine makers. At the time many companies were leaving the business due to class action lawsuits. Kennedy and other critics have complained that the program shields vaccine makers from litigation and is too stingy in compensating injured patients.

FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths

August 6, 2025

U.S. health officials have issued warnings on two separate Boston Scientific heart devices recently linked to injuries and deaths. The agency said Wednesday an issue with defibrillator wires could cause the implants to fail to deliver adequate electrical shocks. The company warned doctors about the issue last month. Separately, the FDA flagged updated instructions for the company’s Watchman heart implant, which is used to reduce the risk of stroke. Boston Scientific said it has seen an increased risk of dangerous blockages in the bloodstream depending on how the device is implanted. The company says the problem is not related to the device design.

In this undated photo provided by the U.S. Food and Drug Administration, Vinay Prasad smiles for a portrait. (U.S. FDA via AP)

FDA vaccine chief leaving agency after less than 3 months

July 30, 2025

Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A spokesperson for the Department of Health and Human Services says Prasad did not want to be a distraction and is leaving to spend more time with his family. Prasad, a longtime critic of the FDA’s leniency in drug approvals, joined the agency in May. He has faced scrutiny over his handling of a gene therapy for a form of muscular dystrophy. In recent weeks he became a target of conservative activists, who noted his past comments criticizing Trump.

Sarepta will resume gene therapy shipments after FDA review of recent patient death

July 28, 2025

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy. The company’s stock has been under pressure for weeks after a series of patient deaths prompted federal regulators to request a pause on the drug’s use. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy, the fatal muscle-wasting disease that affects boys. The Food and Drug Administration said late Monday it recommended resuming shipments for some patients after reviewing the situation. The review included the conclusion that the recent death of an 8-year-old boy was unrelated to the company’s therapy.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

July 22, 2025

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators. The company said late Monday it would comply with a Food and Drug Administration request to halt distribution of Elevidys. The decision comes just days after the company rebuffed FDA regulators in an extremely unusual decision. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy. The fatal muscle-wasting disease affects boys and young men, resulting in early death. Company shares continued to slide in early trading Tuesday morning.

FDA names former pharmaceutical company executive to oversee US drug program

July 21, 2025

The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program. Dr. George Tidmarsh is the founder and former CEO of several drugmakers. He was named Monday to run the FDA’s center for drugs, which employees nearly 6,000 staffers. His appointment comes a month after the center’s acting director announced her retirement. As the agency’s top drug regulator, Tidmarsh would be tasked with following through on a number of commitments by the Trump administration. That includes reviewing the 25-year-old approval of the abortion pill mifepristone.

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

July 19, 2025

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy. The Food and Drug Administration made the request Friday after the confirmation of a third death receiving one of its treatments for muscular dystrophy. The company’s decision not to comply is highly unusual. The FDA says officials met with Sarepta executives and requested the halt in sales. Sarepta says in a statement that its scientific review showed no new safety concerns for younger patients with Duchenne’s muscular dystrophy. The company said it plans to keep the drug, Elevidys, available for those patients.

FDA requires updated warning about rare heart risk with COVID shots

June 25, 2025

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines. The Food and Drug Administration announced the update Wednesday, providing more detail about the problem and the number of people who may be affected. Pfizer and Moderna have added the information to their labels and pamphlets for patients. Myocarditis, a type of heart inflammation that is usually mild, emerged as a rare effect with the first COVID-19 shots, mainly in boys and young men. Earlier vaccine labeling advised doctors about the issue. The new warning covers a larger group.

FDA to offer faster drug reviews to companies promoting ‘national priorities’

June 17, 2025

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans’ health. The new program announced Tuesday aims to review select drugs in just one to two months. It was announced by FDA Commissioner Marty Makary, who has promised “faster cures” since arriving at the agency in April. Makary says the FDA will begin offering special vouchers to drugmakers who are “aligned with U.S. national priorities.” The FDA already has a variety of programs designed to speed up drug reviews, but they all have fairly strict medical criteria.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)

Second patient death reported with gene therapy for muscular dystrophy

June 16, 2025

Shares of Sarepta Therapeutics have plunged again after the drugmaker reported a second death in connection with its gene therapy for muscular dystrophy. The biotech drugmaker said Sunday it was pausing shipments of the drug for patients who are no longer able to walk. The one-time treatment is the first gene therapy approved in the U.S. for the rare muscle-wasting condition. The company has faced scrutiny since its accelerated approval in 2023. Sarepta says it will pause a study of the therapy and assemble an expert panel to recommend new safety protocols for taking the drug.

This photo provided by the FDA in January 2024 shows bottles of Neptunes Fix Elixir, a product labeled to contain tianeptine. (FDA Office of Regulatory Affairs, Health Fraud Branch via AP)

‘Gas station heroin’ is technically illegal and widely available. Here are the facts

June 14, 2025

Health officials want you to think twice before buying brightly colored energy shots and supplements often sold at gas stations, convenience stores and smoke shops. The products are sometimes called “gas station heroin,” and contain tianeptine. That’s an antidepressant that can be addictive and carries the risk of serious side effects. U.S. poison control centers have reported a steady rise in calls linked to the drug for more than a decade. The drug has never been approved by the FDA for any medical condition in the U.S. and cannot legally be added to foods and beverages or sold as a dietary supplement. About a dozen states have prohibited or restricted tianeptine.

MATTHEW PERRONE Health Writer.