Wegovy has been approved by the US Food and Drug Administration (FDA) for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advance fibrosis but without cirrhosis.

What it means is that FDA has granted approval to Novo Nordisk's once-weekly 2.4 mg semaglutide subcutaneous injection for treating a liver cell damage, formerly known as NAFLD or nonalcoholic fatty liver disease. This is a condition where excess fat builds up in the liver, unrelated to heavy alcohol use. It is characterized by fat accumulation in the liver, inflammation, and liver cell damage that could potentially lead to fibrosis and cirrhosis. It is also closely linked to metabolic disorders like obesity and type 2 diabetes, which can be treated by Wegovy. Furthermore, the condition is also closely associated with high cholesterol.

ALSO READ: How To Identify A Counterfeit Ozempic? Look For These Signs

How Was The Approval Given?

The accelerated approval was given on the basis of part-one results from an ongoing two-part, phase 3 ESSENCE trial. This is where Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis. It also showed a resolution of steatohepatitis with no worsening of liber fibrosis as compared with placebo at week 72. The results were also published in April in The New England Journal of Medicine.

How Was The Trial Conducted?

The trial involved a total of 800 participants, who were assigned to either Wogovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 54. Most patients were white, which comprised of the 67.5% of the participants, 57.1% of them were women and 55.9% of them were the patients with type 2 diabetes, while 31.3% of them (around 250 patients) had stage II fibrosis and 68.8% (550 patients) had stage II fibrosis.

It was noted that the patients were on stable doses of lipid-lowering , glucose-management, and weight loss medications.

At week 72, the trial’s first primary endpoint revealed that 63% of the 534 participants receiving Wegovy achieved resolution of steatohepatitis without worsening liver fibrosis, compared to 34% of the 266 participants on placebo, a statistically significant outcome.

For the second primary endpoint, 37% of those treated with Wegovy showed improvement in liver fibrosis without worsening steatohepatitis, versus 22% in the placebo group, again demonstrating a significant difference.

READ MORE: Weight Loss Drugs Like Ozempic, Mounjaro And Wegovy Under Scrutiny After Deaths And Pancreatitis Reports in UK

What Lies Ahead For Wegovy?

Novo Nordisk has moved forward with key regulatory submissions for its obesity treatments in 2025. The company filed for approval of its therapies in the European Union in February, followed by a regulatory submission in Japan in May. That same month, the U.S. Food and Drug Administration (FDA) accepted a filing for oral semaglutide 25 mg.

Looking ahead, part 2 of the ESSENCE trial is expected to report results in 2029. The study is designed to evaluate whether Wegovy can reduce the risk of liver-related clinical events in patients with metabolic dysfunction–associated steatohepatitis (MASH) and F2 or F3 fibrosis, compared with placebo, over 240 weeks.

While Novo Nordisk has the technology to manufacture semaglutide in pill form, the company emphasized that the U.S. launch of oral semaglutide for obesity will depend on portfolio priorities and manufacturing capacity. The higher-dose 50 mg oral version has not yet been submitted to regulators.

“The oral form requires more active pharmaceutical ingredient (API),” a spokesperson told Medscape Medical News. “With a fixed amount of API, the injectable form allows us to treat more patients. We are expanding oral and injectable production capacities worldwide, but it takes time to build, validate, and scale these processes.”

Glenmark, a leading Indian drugmaker, has recalled its products in the US over manufacturing issue, confirmed the US Food and Drug Administration (USFDA).

What Did The USFDA Say?

The USFDA released an Enforcement Report, which noted that the US-based unit of Glenmark Pharmaceuticals in recalling 26,928 packs of oral contraceptive medicines in the US. The company's unit based in Mahwah, New Jersey, has now recalled the affected lot of the following birth control pills:

• Viorele
• Desogestrel
• Ehinyl Estradiol

The report also noted that Ethinyl Estradiol tablets were recalled due to "failed impurities and degradation specifications". The affected drugs were produced in the company's Mumbai headquarters' Goa manufacturing facility. This is because India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.

The drug firm also issued a notice for Class II nationwide recall on September 3, 2025.

What Does Class II Recall Mean?

The USFDA notes that recalls are actions taken by the firm to remove and product from the market and could be conducted by company's own initiative, or by the FDA request or order.

Class II recall means a situation in which the use of or the exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequence is remote.

What Are The Different Categories Of Recalls?

As per the USFDA, there are 5 different categories of recalls, namely:

• Class I Recall
• Class II Recall
• Class II Recall
• Market Withdrawal
• Medical Device Safety Alert

• Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

• Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

• Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

• Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

• Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.

Are There Any Other Drugs Being Recalled?

Dr Reddy's Laboratories, another major Indian drugmaker, has also recalled its muscle relaxant in the US. The company's Princeton, New Jersey-based subsidiary has recalled 571 vials of Succinylcholine Chloride Injection. The recall was initiated due to "out-of-specification results during the 6-month stability testing," according to USFDA.

Donald Trump Health News: A British cardiologist and adviser to Health Secretary Robert F. Kennedy Jr. has suggested that President Donald Trump may seem “slowed down” because of his medications. Speaking to the European Parliament, Dr. Aseem Malhotra, who works with the lobby group Make America Healthy Again, said the 79-year-old president could be experiencing fatigue from cholesterol-lowering drugs, such as statins, and aspirin. Keep reading to know how.

Cardiologist Suggests Trump’s Medications Could Be Slowing Him Down

A British cardiologist and adviser to Health Secretary Robert F. Kennedy Jr., Dr. Aseem Malhotra, has suggested that President Donald Trump may appear to be slowing down due to his medications. Speaking to the European Parliament at the launch of the health advocacy group Make Europe Healthy Again (MEHA), Malhotra pointed to cholesterol-lowering drugs, or statins, and aspirin as potential contributors to fatigue in the 79-year-old president, as per The Independent.

Statins May Offer Little Benefit for Healthy Seniors

Malhotra noted that Trump takes two cholesterol-lowering medications despite having no history of cardiovascular disease. “If you’re over 75 and have no cardiovascular disease, the benefit of statins is very limited,” he said. “You would have to treat 446 people to prevent a single cardiovascular event, meaning there’s no significant benefit.”

Malhotra, known for his skepticism toward vaccines and statins, has previously been criticized by medical experts for promoting views considered misinformation. He has also been a close ally of Kennedy.

Donald Trump's Health Update

Malhotra’s comments come amid ongoing speculation about Trump’s cognitive and physical health. Observers have pointed to occasional gaffes and name mix-ups as possible signs of cognitive decline. Despite this, the White House maintains that the president is in “excellent overall health,” following a recent routine check-up at Walter Reed Medical Center.

Physical health concerns have also been raised after Trump was frequently photographed with bruising on his right hand. White House officials attribute this to frequent handshakes and his use of aspirin for cardiovascular protection. Earlier this year, the president was diagnosed with chronic venous insufficiency, a common, non-life-threatening condition in older adults that affects blood flow from the legs to the heart.

Statin Side Effects and Trump’s Energy Levels

During his remarks, Malhotra highlighted that cholesterol medications can cause fatigue, muscle pain, and “brain fog.” He suggested that Trump might be experiencing a slight slowdown due to these drugs, in addition to possibly sleeping only four hours a night. Malhotra recommended that the president consider stopping statins and aspirin, saying he would likely feel better within weeks.

COVID-19 Booster and Health Status

Malhotra also commented on Trump receiving an updated COVID-19 booster and a flu shot, calling them unnecessary. “I believe he genuinely took the booster and wasn’t doing it for appearances,” Malhotra said, while also noting that Trump may have fallen victim to medical misinformation.

However, research continues to show that COVID-19 vaccines remain effective, particularly for those over 65. A study by the VA St. Louis Healthcare System involving nearly 300,000 veterans found that last season’s vaccine reduced emergency room visits by 29%, hospitalizations by 39%, and deaths by 64%. Combined, the overall effectiveness was around 28%, similar to flu vaccines, which typically provide 30–60% protection against severe illness.

While statins are not proven to cause dementia, the FDA issued a safety warning in 2012 noting that they can sometimes lead to “notable, but poorly defined memory loss or impairment,” which typically reverses after stopping the medication.

President Donald Trump announced that the cost of Novo Nordisk’s widely used diabetes and weight-loss drug, Ozempic, will be reduced. Speaking at a White House event focused on fertility treatments and drug pricing, Trump said the lower prices would follow prompt negotiations with the pharmaceutical company. “They’ll be much lower,” he told reporters, as per Fox News.

Trump Announces Plans To Cut Ozempic Costs

Novo Nordisk produces both Ozempic and Wegovy, which contain the same active ingredient, semaglutide, but are approved for different purposes. Ozempic, approved in 2017, is primarily used to treat Type 2 diabetes, with weight loss occurring as a side effect. Wegovy, approved four years later, is specifically intended for long-term weight management in adults who are obese or overweight and have at least one weight-related condition, such as high blood pressure or Type 2 diabetes. In recent years, demand for both drugs has surged, especially among people looking to lose weight.

During a Thursday Oval Office news conference focused on in vitro fertilization drugs, President Trump mentioned the idea of lowering prices for other medications, including Ozempic. His Centers for Medicare and Medicaid Administrator, Dr. Mehmet Oz, later cautioned that nothing had been finalized.

“In London, the same drug costs $130, but in New York, it’s $1,300,” Trump said during Thursday’s IVF announcement. “Now, instead of $1,300, people will be paying around $150.”

Still, Trump’s remarks generated significant attention. Patients struggling with the high cost of these drugs expressed hope for more affordable access, while doctors called the potential price reduction “huge for patients.” Wall Street also reacted: shares of Novo Nordisk and Eli Lilly, makers of GLP-1 drugs such as Ozempic, Wegovy, Mounjaro, and Zepbound, dropped sharply, erasing tens of billions of dollars in market value.

Novo Nordisk Shares Fall After Trump’s Comment

Shares of Eli Lilly & Co. and Novo Nordisk dropped in late trading after President Trump suggested that the price of the popular diabetes drug Ozempic could fall to about $150 per month. Currently, the U.S. list price for a month’s supply is around $1,000, with Trump referring to it as “the fat loss drug.” In response, Novo’s American depositary receipts fell up to 4.7 percent, while Lilly’s shares dropped as much as 5.3 percent.

Novo Nordisk has been in discussions about lowering drug costs since Trump sent letters to 17 major pharmaceutical companies urging price cuts. Ozempic and its counterpart, Wegovy, were also selected for price negotiations under the Inflation Reduction Act (IRA).

Most Favored Nation’ Drug Prices

President Trump has recently struck deals with Pfizer, AstraZeneca, and EMD Serono under the ‘Most Favored Nation’ pricing framework, with more agreements promised. These deals offer medicines at Most Favored Nation prices to Medicaid, which already receives substantial discounts, and to certain drugs available directly to consumers without insurance through the TrumpRx platform.

In exchange, pharmaceutical companies receive relief from potential tariffs, provided they continue investing in U.S. manufacturing and research.