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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FDA Approves New Drug For Rare Disorder That Turns Muscles Into Bone: What Is Fibrodysplasia Ossificans Progressiva?

Updated Sep 27, 2026 | 10:30 PM IST

SummaryThe US Food and Drug Administration recently approved the third drug to treat rare genetic disorder, fibrodysplasia ossificans progressiva, that causes abnormal formation of bone outside the skeleton.
FDA Approves New Drug For Rare Disorder That Turns Muscles Into Bone: What Is FOP?

Credit: AI

reaImagine developing a strange medical condition in which an injury or even a minor fall may trigger a process that may gradually turn muscles, tendons and ligaments into bone.

This is what fibrodysplasia ossificans progressiva (FOP), one of the world’s rarest genetic disorders, looks like.

The US Food and Drug Administration recently approved a new treatment option for FOP called Atebrioz (zilurgisertib), a once-daily pill developed by Mirum Pharmaceuticals.

Adults and children aged 12 years and above with FOP are eligible for this treatment. It is designed to reduce the formation of new bone outside the skeleton.

What Is Fibrodysplasia Ossificans Progressiva?

FOP is a rare genetic disease in which connective tissues like muscles, tendons and ligaments gradually turn into bone. The abnormal bone formation is known as heterotopic ossification, meaning bone starts to develop in places where it should not.

Over time, this can pose restriction in movement, cause deformities and lead to severe disability. The condition could affect quality of life significantly as well as shorten life expectancy.

FOP is usually diagnosed in childhood. According to Mirum, around 300 people in the US and about 900 worldwide are known to have the condition.

Also read: New RNA Therapy For ALS, The Disease Stephen Hawking Had: Patient With Rare Motor Neuron Disease Improves

Why Does The Body Starts Making Bone In The Wrong Places?

FOP is caused by mutations in a gene involved in bone growth, especially the ACVR1 gene, which produces a protein called activin A receptor type-1, or ALK2. In people with FOP, this pathway becomes abnormally active. As a result, the body can start producing bone within soft tissues.

This process can occur in episodes called flare-ups. Trauma, surgery or other triggers can sometimes provoke inflammation and subsequent abnormal bone formation. The problem is that once mature bone has formed in these tissues, it can permanently restrict movement.

Also read: Rare Pregnancy Infections Linked To 3-Fold Higher Autism Risk: What Is TORCH?

More About The New Drug

Atebrioz contains zilurgisertib, an oral drug that blocks ALK2, the protein that is abnormally active in most people with FOP and triggers bone formation outside the skeleton.

The aim is not to remove bone that has already formed. Instead, the treatment is designed to reduce the formation of new abnormal bone.

FDA’s approval was based on a randomised, placebo-controlled trial involving 63 people with FOP. Participants received either zilurgisertib or placebo for 24 weeks, followed by an extension period.

At week 24, patients receiving Atebrioz had an average 3.2 cm³ decrease in the volume of newly formed abnormal bone, compared to a 24.6 cm³ increase in the placebo group. The FDA said the difference supported the drug’s effectiveness in reducing new heterotopic ossification.

Also read: Claude AI Discovers Novel CRISPR-Like Enzyme System: What Are The Implications For Gene Editing?

Symptoms & Treatment Of FOP

The disease can vary between individuals, but abnormal bone formation can progressively restrict movement. People with FOP may develop difficulty moving their neck, shoulders, spine, hips and other joints as new bone forms around them.

The condition can eventually affect mobility substantially. Extra bone formation can also interfere with everyday activities and contribute to severe disability.

Another characteristic feature is that people with FOP are often born with abnormalities of the big toes, which can help doctors recognise the rare condition early.

Atebrioz is not the first FDA-approved treatment for FOP. The FDA approved Sohonos (palovarotene) in 2023 as the first treatment for the disease.

More recently, the FDA approved Pasatru (garetosmab-grts) in August 2026, making Atebrioz the third FDA-approved treatment for FOP. The newer options differ in how they target the abnormal bone formation.

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Mpox Case Detected In Congo’s Ituri Amid Ebola Outbreak: Why Are Health Officials Concerned?

Updated Sep 27, 2026 | 09:00 PM IST

SummaryAn mpox case detected in Ituri's Bunia in DR Congo has threatened to burden an already overwhelmed healthcare system grappling with the country's largest Ebola outbreak.
Mpox Case Detected In Congo’s Ituri Amid Ebola Outbreak: Why Are Health Officials Concerned?

Credit: AI

A confirmed case of mpox has been detected in Bunia, the capital of Ituri province in the Democratic Republic of Congo (DRC), where health authorities are already battling the country's largest-ever Ebola outbreak.

The development has raised concerns about the additional pressure on an already stretched outbreak response and the overall healthcare system.

The mpox case was confirmed after a 21-year-old woman was hospitalised with skin lesions that ae commonly seen in mpox.

The two viruses are not associated with each other, but the threat of two highly infectious diseases is now being navigated in the same area at the same time.

Mpox Case In Congo Amid Ebola Outbreak

Ituri is at the centre of one of the worst Ebola outbreaks the country has ever seen. As of September 23, the DRC reported 7,890 confirmed Ebola cases and around 3,799 deaths. The a case-fatality ratio, according to WHO, stayed put at 48.1%. Ituri, the epicenter of the outbreak, solely accounted for 6,032 confirmed cases.

The Ebola outbreak has also expanded geographically, with new cases reported across 63 health zones in seven provinces. The WHO says the continued spread is increasing the risk of cross-border transmission.

The appearance of mpox in Bunia, against the backdrop of Ebola, creates another challenge for surveillance, testing, infection prevention and safety of healthcare workers.

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

What Is Mpox?

Mpox is a viral disease that can cause fever, swollen lymph nodes, muscle aches, and peculiar rash or skin lesions. It spreads mainly through close physical contact with an infected person.

Some people recover without complications, while others can develop serious symptoms, particularly those with weak immune systems.

The newly case is especially alarming as the DRC had declared an end to mpox as a national public health emergency in April, following a three-year outbreak that resulted in more than 34,000 confirmed cases nationwide.

Also read: Canada Confirms Clade 1 Strain of Mpox: Know How It Impacts Human

Burden On An Already Overwhelmed Healthcare System

The two diseases are caused by different viruses and spread differently. A confirmed mpox case does not indicate that Ebola has mutated or that the two outbreaks are connected.

The WHO says the Ebola response is already operating under difficult conditions, with conflict, insecurity, population displacement and limited access to basic services hampering surveillance, contact tracing, infection prevention and timely care.

The concern is that health systems, that were already dealing with a major outbreak, now have another infection to detect, investigate and contain.

Bunia is not just another location where a case has been detected. It is the capital of Ituri, where the Ebola outbreak is the most concentrated.

WHO teams have described Bunia as a key operational hub for the response, with flights transporting healthcare workers, medicines and other supplies to affected regions.

The immediate priority will be investigation, contact tracing, and surveillance to determine whether the case is linked to a wider cluster.

DRC is already conducting extensive contact monitoring for Ebola. As of September 23, more than 32,000 people were listed for follow-up, depicting the scale of the response.

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FDA Approves New Parkinson’s Drug That Targets Dopamine Receptors: All About Tavapadon

Updated Sep 27, 2026 | 06:00 PM IST

SummaryThe US Food and Drug Administration recently approved a new drug for Parkinson's disease that works by stimulating dopamine receptors.
FDA Approves New Parkinson’s Drug That Targets Dopamine Receptors: All About Tavapadon

Credit: AI

The US Food and Drug Administration has approved tavapadon, a once-daily oral medicine for adults with Parkinson’s disease. This has added a new option to Parkinson's treatment strategy that has long relied on drugs that mimic the brain’s dopamine supply. The drug will be sold in the US under the brand name Juvmo.

Tavapadon is different from traditional dopamine agonists because it selectively targets D1 and D5 dopamine receptors. It has been studied both as an early treatment and alongside levodopa in people with more advanced Parkinson’s disease and motor fluctuations.

Parkinson’s Disease & Dopamine

Parkinson’s disease is a progressive neurological disorder in which dopamine-producing nerve cells in a region of the brain called the substantia nigra disappear gradually.

Dopamine is essential for controlling movement. As its levels fall, people can develop symptoms like tremor, stiffness, slowness of movement and problems with balance.

This is why many Parkinson’s treatments entail increasing dopamine levels or mimicking its effects in the brain.

How Does Tavapadon Work?

Also read: Parkinson’s Is Rising Across US, But Not Equally: Why Are Some States Seeing More Cases Than Others?

Tavapadon is a selective D1/D5 partial dopamine agonist. It means that it does not simply increase the amount of dopamine in the brain. Instead, it binds to particular dopamine receptors and partially activates them, essentially helping reproduce some of dopamine’s signalling effects.

Most currently available dopamine agonists target D2/D3 receptors. Tavapadon’s D1/D5 is therefore one of its distinguishing characteristics. Researchers have been investigating whether this drug can can help provide motor symptom relief while avoiding some adverse effects linked with dopamine receptor activation.

The FDA’s approval was supported by the phase 3 TEMPO clinical programme. In TEMPO-1, which involved 529 people with early Parkinson’s disease, both 5 mg and 15 mg daily doses of tavapadon significantly improved motor function compared to placebo after 26 weeks.

The drug has also been studied in people already taking levodopa who experience motor fluctuations, a common problem with progressive Parkinson’s. In the TEMPO-3 trial involving 507 participants, adding tavapadon to levodopa increased daily 'on' time without troublesome dyskinesia compared to placebo.

As Parkinson’s disease progresses, some people taking levodopa experience periods when the medicine is working well and movement improves. This is called 'on' time. When the medication’s effect wears off and Parkinson’s symptoms return, it is called 'off' time.

Treatment aims to increase 'on' time while limiting troublesome involuntary movements, known as dyskinesia.

Side Effects Of Tavapadon?

Tavapadon was generally tolerated in the clinical trials, but it is not free of side effects. In the TEMPO-1 trial, the most commonly reported adverse events were:

  • Nausea
  • Headache
  • Dizziness

The FDA’s approval follows data showing improvement in Parkinson’s symptoms, but longer-term safety remains an important factor that needs more investigation.

Dopamine agonists can also be associated with sleepiness, low blood pressure on standing, hallucinations and impulse-control disorders. These issues remain relevant when doctors consider where tavapadon fits into an individual’s treatment plan.

Tavapadon treats the symptoms of Parkinson’s disease. It does not restore the dopamine-producing nerve cells that have been lost or stop the neurodegenerative process.

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