FDA Has Approved A New Medication Treatment For Migraines In Adults

Updated Feb 6, 2025 | 05:09 PM IST

SummaryMany people use the terms ‘migraine’ and ‘headache’ interchangeably. This leads many people to believe that migraines are not as serious as people make them out to be, and that cannot be more wrong, migraines have a major effect on a person’s lifestyle and the new approved medication may prove to be a great relief!
(Credit-Canva)

(Credit-Canva)

Headaches are a common symptom of a stressful lifestyle, your body not feeling well and other issues. While headaches can be dealt with easily, migraines are not so easy to handle. Migraines are a type of headache that feels like severe throbbing and pulsing sensation, almost like you are hearing your own heartbeat in your brain, usually on one side of the brain. Many people believe that migraines are not that big of a deal because you just have to deal with the pain, but that is not all migraine is, some people find it very difficult to do their daily tasks as they experience dizzying spells, nausea and extreme sensitivity to light and sound! These attacks can last hours and make it difficult for people to go about their daily lives as well. While there are medications available for migraine patients, these medications need time to take effect, so you may be in a lot of pain, but there are not many quick reliefs you can have in place other than learning the symptoms of a migraine attack and taking medication before it happens. But a new approval by the FDA may change this!

The U.S. Food and Drug Administration (FDA) has approved Symbravo, a new medicine to treat acute migraine attacks in adults. This means adults can now use Symbravo to get relief from their migraine symptoms. The FDA's decision was based on the results of three big studies, called Phase 3 trials. These trials involved over 21,000 migraine attacks, so the FDA has a lot of information about how well Symbravo works and how safe it is. The FDA only approves medicines that have been shown to be both safe and effective through a thorough testing process.

Importance of New Treatment Option

"Migraine attacks can happen suddenly and really mess up people's lives. It's estimated that over 39 million people in the U.S. alone get migraines," said Herriot Tabuteau, M.D., CEO of Axsome Therapeutics told US News. This shows how common migraines are and how important it is to have good treatments. "Symbravo gives patients and doctors a new option that can quickly stop a migraine attack, keep it away, and let people get back to their normal activities, all with just one dose." Having a medicine that can give fast and long-lasting relief from migraine pain is a big deal for millions of people. This new treatment is a real step forward in how we treat migraines.

Symbravo Trial Results, How Was It Approved

The trials took place in 3 steps, the Momentum trial study focused on people whose migraines had moderate to severe pain. The results showed that a lot more people taking Symbravo felt pain-free two hours after taking the medicine compared to those who took a placebo which is a dummy pill. Even better, many people felt relief for up to 24 and even 48 hours after just one dose. This long-lasting relief is really important for people with migraines because it means they can get back to their normal lives without worrying about the pain coming back. The study also looked at how many people were free from their worst symptom, like sensitivity to light or sound, or nausea. Symbravo worked better than the placebo in this area too.

While the intercept trial looked at people who took Symbravo when their migraine pain was still mild. Even when the pain was just starting, Symbravo was effective. The results were similar to the MOMENTUM trial, with many people getting pain relief and relief from their worst symptoms. Treating migraines early is often better because it can stop the pain from getting really bad.

And lastly the Movement trial which was to see how safe the medication is when people take it regularly. This study followed 706 people who had at least two migraines a month. The most common side effects people experienced were sleepiness and dizziness. While these side effects are important to know about, the study showed that Symbravo is generally safe for people to use on a regular basis.

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Ozempic, Wegovy, Mounjaro and Zepbound May Fuel Rare Brain Disorder, Study Finds

Updated Sep 15, 2026 | 09:00 AM IST

SummaryPublished in Clinical Nutrition, the study identified 15 cases of Wernicke’s encephalopathy (WE) among people taking GLP-1 medications containing semaglutide or tirzepatide. It was linked deficiency caused by GLP-1 drugs, in particularly of vitamin B1, also known as thiamine.
Ozempic, Wegovy, Mounjaro and Zepbound May Fuel Rare Brain Disorder, Study Finds

Credit: iStock

Popular GLP-1 drugs Ozempic, Wegovy, Mounjaro and Zepbound have transformed the treatment of type 2 diabetes and obesity. However, a new study suggests they may be linked to a rare but serious brain disorder caused by vitamin B1 (thiamine) deficiency.

Researchers from Israel’s Sheba Medical Center identified 15 cases of Wernicke’s encephalopathy (WE) among people taking GLP-1 medications containing semaglutide or tirzepatide.

The findings suggest that nutritional deficiencies, particularly of vitamin B1, also known as thiamine, may contribute to the development of Wernicke’s encephalopathy.

What Did the Study Find?

Published in Clinical Nutrition, the study examined 195,979 cases and identified 15 reports of WE in 2023 and 2024.

Most patients experienced gastrointestinal problems, including severe vomiting, loss of appetite, malnutrition or rapid weight loss. These factors can reduce food intake and increase the risk of vitamin B1 deficiency.

Only two patients had the classic symptoms of WE: altered mental status, difficulty walking and abnormal eye movements.

Researchers described the findings as a potential safety signal and called for greater clinical awareness, particularly among patients experiencing severe gastrointestinal symptoms.

“WE is a potentially rare but severe adverse event of GLP-1 RA treatment, mainly with semaglutide or tirzepatide,” the researchers said. “As early detection may prevent neurological sequelae, increased clinical awareness is warranted, especially in individuals experiencing severe gastrointestinal symptoms.”

Can GLP-1 Drugs Cause Vitamin Deficiency?

GLP-1 drugs suppress appetite and can reduce food intake, potentially limiting consumption of vitamin B1-rich foods such as pork, fish and whole grains.

Vitamin B1 is essential for proper nerve function. Without enough of it, patients can develop confusion, problems with balance and coordination, and abnormal eye movements.

In its early stages, thiamine deficiency can cause vague, nonspecific symptoms such as headaches, fatigue, irritability and abdominal discomfort.

Researchers said the findings should help doctors educate patients about the potential risk and monitor for warning signs.

What Is Wernicke’s Encephalopathy?

Wernicke’s encephalopathy is a rare neurological disorder caused by severe vitamin B1 deficiency. Symptoms can include confusion, problems with coordination and abnormal eye movements.

The classic symptom triad is often absent, making the condition difficult to recognize. If untreated, WE can cause permanent neurological damage, progress to Korsakoff syndrome or result in death. Korsakoff syndrome is a permanent condition marked by memory loss, confusion, and changes in personality.

Should You Take Supplements?

Experts do not recommend routinely taking supplements with GLP-1 drugs unless a deficiency is confirmed or nutritional needs cannot be met through diet.

A balanced diet containing fruits and vegetables, whole grains, nuts and seeds, dairy or fortified alternatives, and lean or plant-based proteins can help maintain adequate nutrient intake.

Experts also caution that products marketed specifically as “GLP-1 support” supplements may have limited evidence behind their claims.

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US FDA To Hold Psychedelic Drug Hearing Amid Trump Push: What It Means For Depression, PTSD

Updated Sep 14, 2026 | 11:27 PM IST

Summary​Emerging research shows psychedelics can help improve mental health, especially in conditions where traditional treatment approaches have not been useful. However, these drugs also come with several health risks that cannot be overlooked.​​
US FDA To Hold Psychedelic Drug Hearing Amid Trump Push: What It Means For Depression, PTSD

Credit: iStock

The US Food and Drug Administration (FDA) has announced to hold a public hearing on the potential therapeutic use of psychedelic drugs, as the Donald Trump administration pushes to accelerate research and development of these treatments for serious mental illnesses.

The hearing, it said, will examine their potential use in supervised and supportive settings, including patient safety, provider training, access and data collection.

In a statement, the FDA said it is collaborating with federal partners and holding “this public hearing to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings”.

What Will The FDA Hearing Discuss?

Also read: Ibogaine: Why Donald Trump Is Pushing US FDA To Fast-track This Psychedelic

The hearing will focus on what would be needed for the potential therapeutic use of psychedelic drugs in supervised and supportive settings.

Key areas include:

  • Provider training and credentialing
  • Patient safety
  • Access to treatment
  • Data collection and standardization

Emerging research shows psychedelics can help improve mental health, especially in conditions where traditional treatment approaches have not been useful. However, these drugs also come with several health risks that cannot be overlooked.

The hearing is part of broader US efforts to increase clinical trial participation, data sharing and real-world evidence on psychedelic drugs. The FDA hearing does not amount to approval of psychedelic treatments. Instead, it could help shape how the US approaches their potential future use in medical care.

What Does This Mean For Depression And PTSD?

The FDA has already taken steps to speed up the development of psychedelic treatments for mental health conditions.

In April 2026, the agency issued national priority vouchers to companies studying psilocybin for treatment-resistant depression (TRD), psilocybin for major depressive disorder (MDD), and methylone for post-traumatic stress disorder (PTSD).

The FDA has also granted Breakthrough Therapy designation to psychedelic drug programs involving MDMA for PTSD and psilocybin for TRD and MDD.

Research over the past decade has suggested that MDMA-assisted therapy may help reduce PTSD symptoms, while psilocybin-assisted therapy has shown promise for treatment-resistant depression in clinical studies.

For people who do not get lasting relief from existing treatments such as antidepressants and psychotherapy, psychedelic-assisted therapy could potentially offer another treatment option.

However, these designations and regulatory steps do not mean that these drugs have been approved as safe or effective treatments. Neither a national priority voucher nor Breakthrough Therapy designation is a substitute for FDA marketing approval.

Read More: Psychedelic Compound Found In 'Magic Mushrooms' May Help Prevent Painful Chemotherapy Side Effects, Study Finds

Why Is The US Accelerating Psychedelic Research?

The push has expanded beyond the FDA. In 2026, the White House, Congress and the Department of Veterans Affairs (VA) have also become involved in efforts to accelerate research into psychedelic treatments, including psilocybin, MDMA and ibogaine.

The US Department of Health and Human Services (HHS) has partnered with the VA to accelerate the development of psychedelic-assisted therapies for veterans with conditions including PTSD, depression and traumatic brain injury.

Separately, a bipartisan group of lawmakers introduced a bill that would require the US Department of Defense to evaluate whether ongoing psychedelic research, particularly involving psilocybin, could benefit active-duty service members and veterans transitioning to civilian life.

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1,370 Mpox Cases, 7 Deaths Reported In July: WHO Says Risk Remains Moderate

Updated Sep 14, 2026 | 09:39 PM IST

SummaryFrom January 1, 2025, to July 31, 2026, a total of 65,784 mpox cases and 264 deaths were reported across 105 countries.​The WHO Director-General's standing recommendations on mpox have been extended until August 2027.
1,370 Mpox Cases, 7 Deaths Reported In July: WHO Says Risk Remains Moderate

Credit: iStock

A total of 1,370 mpox cases and seven deaths were reported globally in July, according to the World Health Organization (WHO), which continues to assess the global public health risk from the multi-country outbreak as moderate.

The WHO external situation report, published today, is based on data from 32 countries across four WHO regions. The case fatality ratio (CFR) was 0.5%.

About three-quarters of the cases were reported in the WHO African Region.

Madagascar Reports Highest Cases

Madagascar reported the highest number of cases, with 703 cases and seven deaths, followed by Angola (138), China (88), the Democratic Republic of the Congo (85) and Kenya (55).

Between July 6 and August 16, Madagascar reported 785 cases, while deaths remained at seven. Angola reported 184 cases, Kenya 94, the Democratic Republic of the Congo 41 and Cameroon 28.

The WHO noted that Congo's figures may be affected by delays in mpox reporting as the country focuses on its response to the Bundibugyo virus disease outbreak.

65,784 Mpox Cases Reported Since January 2025

From January 1, 2025, to July 31, 2026, a total of 65,784 mpox cases and 264 deaths were reported across 105 countries.

“WHO conducted a global mpox rapid risk assessment in August 2026; the overall global public health risk associated with the mpox multi-country outbreak was again assessed as moderate,” the WHO said.

“WHO continues to consider the ongoing multi-country mpox outbreak a graded emergency, with new outbreaks reported in multiple countries and over a thousand confirmed cases reported every month,” it added.

The WHO urged countries and partners to maintain mpox surveillance, notification and coordinated preparedness and response activities.

The WHO Director-General's standing recommendations on mpox have been extended until August 2027.

Clade Ib Mpox Spreads

Mpox transmission continues to affect key populations, largely through sexual transmission, followed by household spread and community outbreaks. All clades of monkeypox virus (MPXV) continue to circulate.

In July, the African Region reported more confirmed cases than in June, while the Americas, Western Pacific, European and South-East Asia regions reported fewer cases. The Eastern Mediterranean Region reported no confirmed cases.

Eleven African countries reported active transmission between July 6 and August 16, with 1,153 confirmed cases and seven deaths.

Chile and Hungary reported clade Ib MPXV for the first time. Several European countries, including the UK, have reported community transmission of clade Ib.

Mpox Vaccine Shows Promising Early Results

The first human trial of BNT166a, an mRNA-based mpox vaccine developed by BioNTech, showed encouraging early results.

The vaccine was generally safe and well tolerated and triggered strong antibody responses across all dose levels, including in people who had and had not previously received vaccination against related viruses.

The trial involved 64 adults and was primarily designed to assess safety and immune responses, rather than whether the vaccine prevents infection.

“These findings are an important step forward in the development of a new generation of vaccines against mpox. We’ve shown that this mRNA vaccine approach can safely generate strong immune responses in people, which is very encouraging," said Professor Saul Faust, UK Chief Investigator for the trial.

The vaccine is now progressing to a larger trial to assess its effectiveness in real-world settings.

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