The logo for the Food and Drug Administration is seen ahead of a news conference at the Health and Human Services Headquarters in Washington, April 22, 2025.

Nathan Posner | Anadolu | Getty Images

A key U.S. Food and Drug Administration official who oversees vaccines and biotech treatments will step down from the agency following multiple decisions that raised concerns within the industry.

Vinay Prasad, director of the Center for Biologics Evaluation and Research, will leave the FDA at the end of April, an agency spokesperson confirmed on Friday. It is his second departure from the position: He briefly left the post in July following backlash over his regulatory decisions, and returned only two weeks later in August.

In a post on X, FDA Commissioner Marty Makary said the FDA will appoint a successor before Prasad returns next month to the University of California San Francisco, where he taught before taking the FDA position last year. Makary said Prasad “got a tremendous amount accomplished” during his tenure at the agency.

Prasad’s decision to step down comes after criticism of the FDA mounted within the biotech and pharmaceutical industry and among former health officials. In the past year, the agency has denied or discouraged the approval applications of at least eight drugs, according to RTW Investments, after taking issue with data the companies used to support their applications. The FDA also initially refused to review Moderna’s flu shot before it later reversed course.

All of those companies accused the FDA of reversing previous guidance about the evidence they could use to back their applications, sparking criticism within the industry that an unreliable regulatory process could stifle development of drugs for hard-to-treat diseases.

A former FDA official who spoke to CNBC on the condition of anonymity to speak freely on the issue called the reversals the worst kind of regulatory uncertainty because companies say they are being told one thing and then experience another.

In a statement earlier Friday, an FDA spokesperson said there was “no regulatory uncertainty,” adding the agency “makes decisions based on the evidence, but does not make assurances about outcomes.” The spokesperson said the FDA is “conducting rigorous, independent reviews and not rubber-stamping approvals.”

The most recent controversy came after the FDA discouraged UniQure from applying for expedited approval of its experimental treatment for Huntington’s disease.

The agency, which underwent staff cuts and an overhaul under Health and Human Services Secretary Robert F. Kennedy Jr., has faced broader backlash for its drug and vaccine approvals process. Critics have worried the agency could stifle the development of new treatments and risk the safety of patients.

The Wall Street Journal earlier reported Prasad’s departure.

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The logo of pharmaceutical company Novo Nordisk is displayed in front of its offices in Bagsvaerd, on the outskirts of Copenhagen, Denmark, Nov. 24, 2025.

Tom Little | Reuters

The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill for obesity from Wegovy maker Novo Nordisk, a landmark decision that health experts say could open up treatment access to more patients.

Novo Nordisk said it expects to launch the pill in early 2026. The Danish drugmaker said starting in early January, the starting dose of 1.5 milligrams will be available in pharmacies and via select telehealth providers with savings offers for $149 per month.

That’s the same price that cash-paying patients can access the starting dose of the pill on President Donald Trump’s direct-to-consumer website, TrumpRx, under a deal Novo Nordisk struck with his administration last month. Trump’s site also launches in January.

Novo Nordisk did not say how much higher doses of the drug would cost, but said additional information on coverage and savings options for eligible patients will be available at that time as well.

Shares of Novo Nordisk gained roughly 10% in extended trading Monday.

The FDA’s approval also clears the pill for use to reduce the risk of major cardiovascular events, such as death, heart attack or stroke, in adults with obesity and established cardiovascular disease, according to Novo Nordisk.

That’s consistent with the approval label of the company’s blockbuster weight loss drug Wegovy, which shares the same active ingredient, semaglutide. Both work by mimicking the gut hormone GLP-1 to suppress appetite.

“What we’ve learned through years of research is that having an oral option really kind of opens up, activates and motivates different segments to seek treatment,” Dave Moore, Novo Nordisk’s executive vice president of U.S. operations, told CNBC ahead of the approval. “To have that conversation with their doctor to see if this is something that might be right for them.”

“That’s what we’re excited about — to be able to give people an option and make sure we have access and ease of access like we have been doing with our injections,” he continued. He added that patients will have the “comfort and familiarity” on the safety and efficacy side since the pill contains the same active ingredient as Wegovy.

Some health experts said pills could reach people who are afraid of needles or patients who might benefit from the existing injections but don’t take them because they don’t view their need as severe enough. 

It’s unclear exactly how many people are using GLP-1s in the U.S., especially for obesity in particular. But around 1 in 8 adults said they were taking a GLP-1 drug to lose weight or treat another chronic condition as of November, according to a poll from health policy research organization KFF.

The approval gives Novo Nordisk a head start over its chief rival Eli Lilly, which is currently the dominant player in the market and is racing to launch its own obesity pill. Pills are the next battleground for the two drugmakers, which established the booming GLP-1 space that some analysts say could be worth roughly $100 billion by the 2030s.

Wall Street thinks there’s plenty of room for pills in the market, with Goldman Sachs analyst saying in August that pills could capture a 24% share — or around $22 billion — of the 2030 global weight loss drug market.

In a note Monday, BMO Capital Markets analyst Evan Seigerman said the approval of Novo Nordisk’s pill gives the company a “much-needed win in light of recent challenges maintaining incretin market share dominance.”

Incretins refer to treatments that mimic gut hormones such as GLP-1. Eli Lilly earlier this year gained the majority share of the market thanks to its blockbuster obesity injection Zepbound, which has shown to be more effective than Novo Nordisk’s Wegovy.

“Novo will likely benefit from first-mover advantage, capturing patients with a preference for convenience and comfort provided by an oral dosing regimen,” Seigerman said. But he also noted that the market is “rapidly evolving with competitive assets in development” and an approval for Eli Lilly’s pill, orforglipron, “just around the corner.”

What to know about the Wegovy pill

The approval is based on a phase three trial that followed more than 300 adults with obesity but not diabetes.

In that study, a 25-milligram dose of Novo Nordisk’s oral semaglutide helped patients lose up to 16.6% of their weight on average after 64 weeks, according to results from the trial presented at a medical conference in 2024. That weight loss was 13.6% when the company analyzed all patients regardless of whether they stopped the drug.

The pill appears to be slightly more effective than an experimental oral drug from Eli Lilly, which is still waiting for FDA approval.

But unlike Novo Nordisk’s pill, Eli Lilly’s treatment is not a peptide medication. That means it is absorbed more easily by the body and does not require dietary restrictions. People who take Novo Nordisk’s pill have to wait 30 minutes before eating or drinking each day.

But Moore said several existing medicines have the same dietary requirements, so “we don’t see it as something that impacts adherence to treatment.” He noted that Novo Nordisk’s research has found that it helps patients to remember to take their medicine in the morning with a few sips of water.

“It’s actually a reinforcement factor for patients,” Moore said.

He added that the prices of the pill get costs closer to what some people are paying for unapproved, compounded versions of branded GLP-1s, some of which are still being illegally mass-marketed and sold in the U.S.

Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn’t have insurance coverage for the costly treatments. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But the agency earlier this year determined that the shortage of semaglutide is over, barring the practice in many cases.

“It continues to be alarming and disturbing for us,” Moore told CNBC, referring to illegitimate ingredients that are imported into the U.S. illegally and used by some compounding pharmacies to create copycat versions of branded GLP-1s.

In terms of manufacturing, Moore said the company is “prepared to be able to satisfy a big demand here in the U.S., and we’re pretty excited about it.” Novo Nordisk said manufacturing is underway at its North Carolina facilities.

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Woman with Signos wearable and app

Source: Signos

The Food and Drug Administration on Wednesday approved the first-ever glucose monitoring system specifically for weight loss from the startup Signos, establishing a new option for Americans to manage their weight. 

Current treatment options for losing weight – popular drugs like GLP-1s and surgical interventions – are typically limited to patients with obesity or a certain BMI. Obesity drugs such as Novo Nordisk‘s Wegovy and Eli Lilly‘s Zepbound can also be difficult to access due to their high costs, limited U.S. insurance coverage and constrained supply.

But now, any patient can purchase a Signos membership to access its system. It uses an AI platform and an off-the-shelf continuous glucose monitor, or CGM, from Dexcom to offer personalized, real-time data and lifestyle recommendations for weight management. 

“There is now a solution that everybody can use to help on the weight loss journey, and you don’t have to be a certain number of pounds to use it. It’s available for the average American who needs it,” said Sharam Fouladgar-Mercer, Signos’ co-founder and CEO, in an interview on Tuesday ahead of the approval. “The average person might have five pounds to lose, or others might have 100 pounds to lose. We are here to help them at any point in that journey.”

The obesity epidemic costs the U.S. health-care system more than $170 billion a year, according to Centers for Disease Control and Prevention data. Almost 74% of Americans are overweight or obese, government data says. Signos hopes it can make a “real big dent in that curve for the betterment of many of us,” Fouladgar-Mercer said. 

Customers who sign up for Signos can choose a three-month or six-month plan, which currently costs $139 and $129, respectively. The company will ship out all of the CGMs a patient needs for the number of months in the plan they choose.  

Insurers currently don’t cover the system for weight management, but the plans are a fraction of the roughly $1,000 monthly price of GLP-1s in the U.S. Signos is working with health insurance companies and employers to get coverage for the system, the company said in a statement to CNBC. Signos said it expects “this to evolve quickly as interest for tackling weight continued to expand.”

The Signos system can be used in combination with GLP-1s or bariatric surgery, said Fouladgar-Mercer. He said patients can also use the system after getting off a GLP-1 to maintain their weight loss. 

CGMs are small sensors worn on the upper arm that track glucose levels, mainly for people with diabetes. That data is wirelessly sent to Signos’ app, which also allows patients to log their food intake and exercise levels, among other information that the AI platform uses to make recommendations. 

Apart from helping people lose pounds, the system aims to help users understand how their bodies respond to specific foods and exercise patterns and make the right behavioral changes to manage and maintain their weight in the long term. 

Signos did not share how many patients are currently using its glucose monitoring system, but Fouladgar-Mercer said tens of thousands of people have already tried it over time. He said Signos has scaled up its CGM inventory and software capacity to “handle a pretty massive scale” following the approval.

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Douglas Ingram, president and chief executive officer of Sarepta Therapeutics Inc., during the Forbes Healthcare Summit in New York, US, on Tuesday, Dec. 5, 2023.

Michael Nagle | Bloomberg | Getty Images

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy treatment appeared at risk.

The Food and Drug Administration will request that the company voluntarily stop all shipments of the treatment, Elevidys, a person familiar with the matter told CNBC.

Sarepta told CNBC it had not heard from the FDA.

Separately, FDA Commissioner Marty Makary said in an interview with Bloomberg News that the agency is considering whether the company’s gene therapy should stay on the market.

The FDA has been investigating two patient deaths tied to Elevidys, which accounts for more than half of Sarepta’s total net product revenue. The company also reported a third death tied to a separate experimental gene therapy.

Elevidys has been mired in controversy even since before it was approved. The gene therapy has yet to clearly prove it can benefit people with Duchenne muscular dystrophy, a condition that erodes muscle function over time.

People with the disease eventually lose the ability to walk, and most die by their early 20s, meaning there’s a huge unmet need for treatment. The FDA in 2023 originally granted Elevidys a conditional approval for patients only between the ages of 4 and 5, the group that saw the most benefit in clinical trials.

The following year, the agency granted the treatment full approval for patients 4 and older who could still walk and accelerated approval for patients 4 and up who could no longer walk. The latter decision was especially contentious because there was less evidence that Elevidys could help people whose disease had already progressed so much.

Plus, Elevidys failed to meet its goal in a Phase 3 trial, though the company contended that the drug showed promise on other metrics in the study. Then head of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, agreed with Sarepta’s assessment and overruled FDA staff to expand approval of Elevidys.

Earlier this year, Sarepta disclosed that two teenage boys died from liver failure after receiving Elevidys. Then this week, reports emerged that another person died during a Phase 1 trial investigating another one of Sarepta’s gene therapies for a different disease.

The two therapies are different, though they share the same method of delivery, heightening the safety concerns around Elevidys. The safety risks of Elevidys are especially important given the uncertain benefit, said BMO analyst Kostas Biliouris.

For example, Novartis’ gene therapy Zolgensma for spinal muscular atrophy has also caused liver toxicity and death, but the benefit of that treatment is clear.

“That’s why deaths here matter so much versus Zolgensma, for example,” Biliouris said.

And Zolgensma is just one drug of many for a large company like Novartis. For Sarepta, Elevidys is everything.

Executives this week tried to reassure investors that even if it can only treat patients who can still walk, where deaths haven’t been reported, the therapy should bring in at least $500 million a year. Sarepta last month stopped shipping Elevidys to patients who can no longer walk while it explores a safer way to administer the treatment.

The top concern for investors at this point is whether the FDA pulls the drug, Biliouris said. The company’s stock has now fallen more than 87% this year.

“If the FDA pulls Elevidys from the market,” he says, “Sarepta is done.”

More CNBC health coverage

Jennifer Handt, whose son was diagnosed with Duchenne muscular dystrophy in late 2020, said it was “heartbreaking” that other patients won’t have a treatment option to turn to if shipments of Elevidys are paused. 

Her son, Charlie, was dosed with Elevidys in 2022 as part of Sarepta’s late-stage trial and noticed improvements in six to 12 months, including increased stamina and more fluid motions. The drug also eased a telltale symptom of the condition called Gowers’ sign, which causes children difficulty when getting up from a sitting or lying position. 

She said her son is “completely stable” three years out from his dose. Handt said she was aware of the liver toxicity risks before Charlie enrolled in the trial.

“We don’t have the luxury of not taking the risk,” Handt said. “There are families that dealt with this disease before that would have done anything to have an option, even if there are risks.” 

“Every family should have the choice to take this leap with this drug and potentially see benefits,” she added. 

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The logo for the Food and Drug Administration is seen ahead of a news conference on removing synthetic dyes from America’s food supply, at the Health and Human Services Headquarters in Washington, DC on April 22, 2025.

Nathan Posner | Anadolu | Getty Images

The U.S. Food and Drug Administration on Tuesday published a warning letter addressed to the wrist wearable company Whoop, alleging it is marketing a new blood pressure feature without proper approvals.

The letter centers around Whoop’s Blood Pressure Insights (BPI) feature, which the company introduced alongside its latest hardware launch in May.

Whoop said its BPI feature uses blood pressure information to offer performance and wellness insights that inform consumers and improve athletic performance.

But the FDA said Tuesday that Whoop’s BPI feature is intended to diagnose, cure, treat or prevent disease — a key distinction that would reclassify the wellness tracker as a “medical device” that has to undergo a rigorous testing and approval processes.

“Providing blood pressure estimation is not a low-risk function,” the FDA said in the letter. “An erroneously low or high blood pressure reading can have significant consequences for the user.”

A Whoop spokesperson said the company’s system offers only a single daily estimated range and midpoint, which distinguishes it from medical blood pressure devices used for diagnosis or management of high blood pressure.

Whoop users who purchase the $359 “Whoop Life” subscription tier can use the BPI feature to get daily insights about their blood pressure, including estimated systolic and diastolic ranges, according to the company.

Whoop also requires users to log three traditional cuff-readings to act as a baseline in order to unlock the BPI feature.

Additionally, the spokesperson said the BPI data is not unlike other wellness metrics that the company deals with. Just as heart rate variability and respiratory rate can have medical uses, the spokesperson said, they are permitted in a wellness context too.

“We believe the agency is overstepping its authority in this case by attempting to regulate a non-medical wellness feature as a medical device,” the Whoop spokesperson said.

High blood pressure, also called hypertension, is the number one risk factor for heart attacks, strokes and other types of cardiovascular disease, according to Dr. Ian Kronish, an internist and co-director of Columbia University’s Hypertension Center.

Kronish told CNBC that wearables like Whoop are a big emerging topic of conversation among hypertension experts, in part because there’s “concern that these devices are not yet proven to be accurate.”

If patients don’t get accurate blood pressure readings, they can’t make informed decisions about the care they need.

At the same time, Kronish said wearables like Whoop present a “big opportunity” for patients to take more control over their health, and that many professionals are excited to work with these tools.

Understandably, it can be confusing for consumers to navigate. Kronish encouraged patients to talk with their doctor about how they should use wearables like Whoop.

“It’s really great to hear that the FDA is getting more involved around informing consumers,” Kronish said.

FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009. 

Jason Reed | Reuters

Whoop is not the only wearable manufacturer that’s exploring blood pressure monitoring.

Omron and Garmin both offer medical blood pressure monitoring with on-demand readings that fall under FDA regulation. Samsung also offers blood-pressure-reading technology, but it is not available in the U.S. market.

Apple has also been teasing a blood pressure sensor for its watches, but has not been able to deliver. In 2024, the tech giant received FDA approval for its sleep apnea detection feature.

Whoop has previously received FDA clearance for its ECG feature, which is used to record and analyze a heart’s electrical activity to detect potential irregularities in rhythm. But when it comes to blood pressure, Whoop believes the FDA’s perspective is antiquated.

“We do not believe blood pressure should be considered any more or less sensitive than other physiological metrics like heart rate and respiratory rate,” a spokesperson said. “It appears that the FDA’s concerns may stem from outdated assumptions about blood pressure being strictly a clinical domain and inherently associated with a medical diagnosis.”

The FDA said Whoop could be subject to regulatory actions like seizure, injunction, and civil money penalties if it fails to address the violations that the agency identified in its letter.

Whoop has 15 business days to respond with steps the company has taken to address the violations, as well as how it will prevent similar issues from happening again.

“Even accounting for BPI’s disclaimers, they do not change this conclusion, because they are insufficient to outweigh the fact that the product is, by design, intended to provide a blood pressure estimation that is inherently associated with the diagnosis of a disease or condition,” the FDA said.

WATCH: Watch CNBC’s full interview with FDA commissioner Dr. Marty Makary

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The Food and Drug Administration on Wednesday approved Gilead’s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help bring the world closer to ending the decadeslong epidemic caused by the virus. 

But the launch of the injectable drug, which will be marketed under the name Yeztugo, faces a set of potential threats, including the Trump administration’s proposed cuts to federal funding for HIV prevention efforts. 

In two groundbreaking clinical trials in 2024, Gilead’s injection proved to be capable of virtually eliminating new HIV infections when taken every six months. That’s a less frequent dosage than for all existing HIV prevention medications, including daily pills from Gilead and another injection, from GSK, taken every other month. 

That makes Yeztugo a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization. 

The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O’Day said in an interview ahead of the approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women.

“It’s hard to overstate the importance of this for global public health,” O’Day said, adding that the injection “really will bend the arc of the epidemic as we roll this out across the globe.”

But the magnitude of its impact will also depend on how easy it is to get, said Jeremiah Johnson, executive director of PrEP4All, an organization focused on expanding access to HIV prevention medications. 

Pricing, access, efficacy

Lenacapavir, the generic name of Yeztugo, has an annual list price of $28,218 in the U.S. before insurance, a Gilead spokesperson said in an email. That is in line with existing branded medications approved for the same use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. 

A month’s supply of Truvada and Descovy, Gilead’s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year. One dose of GSK’s Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.

“We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,” the Gilead spokesperson said, adding that there is broad insurance coverage for existing prevention options.

The company said it has a copay savings program for eligible insured patients that may reduce out-of-pocket payments for Yeztugo to as little as zero dollars. Gilead also has a program for eligible uninsured people to receive the injection for free.

Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year. One analysis in 2024 found that the drug could be made for as little as $26 to $40 a year.

Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment.

O’Day said the company is also committed to supplying the drug for that use globally as the virus “knows no boundaries.” Gilead in October granted licenses to six generic manufacturers to produce and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries.

Gilead also promised to supply doses for up to 2 million people at no profit before those generic versions come to the market, O’Day said. 

PrEP has been available for a decade in the form of daily pills, but infections have climbed or remained roughly flat in many areas. Pills can be difficult for many people to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in many communities, particularly outside the demographic of white men who have sex with men.

Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users, according to AIDSVu, a public resource for HIV surveillance data from Gilead in partnership with Emory University’s Rollins School of Public Health.

“Unfortunately, there’s still enormous amount of stigma and cultural challenges when it comes to HIV prevention,” Johanna Mercier, Gilead’s chief commercial officer, said in an interview. “Getting a twice-a-year injection really gives you that privacy that people have been looking for.”

She said Gilead aims to ensure that more people, especially those not currently using PrEP, are aware of that convenience advantage and the efficacy of the company’s injection.

In one late-stage trial, 99.9% of patients who took Gilead’s injection did not contract an infection. There were only two cases among more than 2,000 patients, effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Gilead’s daily pill Truvada. The study enrolled cisgender men, transgender women, transgender men and gender nonbinary individuals who have sex with partners assigned male at birth.

Another trial, on more than 5,000 cisgender women, found that none of the roughly 2,000 participants who received Gilead’s injection contracted an HIV infection, demonstrating 100% efficacy. 

Proposed federal funding cuts pose a threat

In the U.S., ensuring access to underserved populations will also require broad insurance coverage. Most PrEP users are under commercial plans, according to the HIV+Hepatitis Policy Institute. But the federal Medicaid program is also crucial to reaching lower-income communities.

Medicaid is the largest source of insurance coverage for people who have the virus in the U.S., covering an estimated 40% of nonelderly adults who have HIV, according to health policy research organization KFF. That makes Republicans’ proposed funding cuts to Medicaid a huge potential threat to HIV treatment and prevention access.

Mercier said that, as of now, Gilead believes that Medicaid will continue to cover HIV services and support.

“There are pretty incredible programs out there, not only Medicaid and other government programs, that really have safety nets to make sure that people who need or want access, both for HIV treatment and prevention, are set up,” she said, also pointing to Gilead’s programs for uninsured individuals.

But PrEP4All’s Johnson said the “entire foundation for HIV prevention in America is under attack at this moment.”

Other proposed federal funding cuts could make it harder to get Gilead’s injection into the hands of physicians and patients, Johnson said. For example, the White House’s proposed budget for fiscal year 2026 includes deep cuts to several HIV prevention programs, particularly those that are run through the CDC.

While some funding streams are continuing, Johnson said they are doing so “in a way that would completely destabilize the entire field of HIV prevention.”

He said if Congress does not push back on the White House’s proposed cuts, people currently taking PrEP “could start to slip off” and HIV infections could rise in many communities. 

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