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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India Proposes Stricter Drug Rules: Tougher Quality Checks, Licence Suspension

Updated Nov 5, 2026 | 05:35 PM IST

SummaryThe proposals include immediate suspension of manufacturing licences for drugs failing specified critical quality tests, stricter microbial monitoring in sterile manufacturing areas, and mandatory authorisation of qualified personnel for batch release.
India Proposes Stricter Drug Rules: Tougher Quality Checks, Licence Suspension

Credit: iStock

The Union Ministry of Health and Family Welfare has proposed three separate amendments to the Drugs Rules, 1945, to strengthen pharmaceutical quality control, manufacturing accountability and patient safety.

The proposals include immediate suspension of manufacturing licences for drugs failing specified critical quality tests, stricter microbial monitoring in sterile manufacturing areas, and mandatory authorisation of qualified personnel for batch release.

The announcements aim to strengthen India's drug regulatory framework and align manufacturing standards with international guidelines.

Immediate Suspension Of Licences For Drugs Failing Critical Quality Tests

Also read: India To Introduce QR Code Verification for Vaccines And Cancer Drugs: Here's What Patients Can Check

In a significant move to enable faster action against substandard medicines, the Ministry has proposed immediate suspension of manufacturing licences for drugs declared Not of Standard Quality (NSQ) on specified critical parameters.

Under the existing provisions, suspension or cancellation of a manufacturing licence involves a prescribed regulatory process, including the issuance of a show-cause notice. This can create a time gap between the identification of a quality failure and regulatory action, during which the drug may remain in circulation.

To address this, the proposed amendment would allow the Central Licensing Approving Authority or the State Licensing Authority, as applicable, to immediately suspend the manufacturing licence upon receiving a Government Analyst's report declaring a drug NSQ on any of the following parameters:

  • Assay
  • Dissolution
  • Related substances
  • Impurities
  • Sterility

These parameters are critical to determining the quality and safety of medicines. The proposed provision seeks to enable prompt intervention and minimise potential risks to patients.

Stricter Microbial Monitoring In Sterile Drug Manufacturing

Read More: Centre Bans Cough & Cold Medicines For Children Under 4: What Parents Need To Know

The Ministry has proposed amendments to Schedule M of the Drugs Rules, 1945, to revise microbial contamination limits in Grade A clean areas in line with the World Health Organization's (WHO) Good Manufacturing Practices (GMP) guidelines for sterile pharmaceutical products.

Grade A areas are critical zones in sterile pharmaceutical manufacturing, where exposed products, containers and sterilised components are handled. Maintaining strict microbial controls in these areas is essential to preventing contamination and ensuring product safety.

The proposed revision addresses differences between the existing Schedule M requirements and WHO guidelines. It also provides for any microbial growth detected in Grade A areas to trigger an investigation, in accordance with WHO guidance.

The amendment aims to strengthen contamination monitoring and bring India's sterile manufacturing standards in line with internationally recognised benchmarks.

The development comes in the backdrop of an episode involving India’s biggest drug maker Sun Pharma, which was recently ordered to halt production at its manufacturing plant in Assam after reports of contamination in some of the eye drops made there.

Mandatory Authorization For Drug Batch Release

In another proposal, the Ministry has sought to make it mandatory for drug manufacturers to formally designate a suitably qualified and experienced person responsible for batch release.

Although manufacturers are currently required to provide details of competent technical staff responsible for manufacturing and testing while applying for licences, the rules do not specifically require them to identify the person authorised to release drug batches.

Under the proposed framework, manufacturers applying for licences under the relevant provisions of the Drugs Rules, 1945, would have to:

  • Designate a qualified and experienced person responsible for batch release.
  • Maintain prescribed records for every batch manufactured.
  • Follow a prescribed format for the Batch Release Certificate.

Batch release is a critical stage in pharmaceutical manufacturing. It involves reviewing quality parameters and relevant documentation before a batch is cleared for distribution.

The proposed requirements seek to establish clear accountability for batch-release decisions, improve traceability and strengthen quality assurance.

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WHO: 63 Countries Have Eliminated At Least One Neglected Tropical Disease By 2026; Why Dengue Remains A Concern

Updated Nov 5, 2026 | 11:48 AM IST

SummaryThe WHO reports that 63 countries have eliminated at least one neglected tropical disease by June 2026, up from 42 in 2020. However, dengue cases reached a record 15.1 million in 2024, highlighting the challenges that remain in tackling NTDs and meeting the WHO's 2030 targets.
WHO: 63 Countries Have Eliminated At Least One NTD By 2026; Why Dengue Remains A Concern

Credit: iStock

The World Health Organization (WHO) has reported significant global progress against neglected tropical diseases (NTDs), with fewer people requiring treatment. However, the rising burden of dengue remains a major concern.

The Global Report on Neglected Tropical Diseases 2026 found that 63 countries had eliminated at least one NTD by June 2026, up from 42 at the end of 2020.

“Elimination of neglected tropical diseases is one of the standout success stories of global health,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

However, he warned that these gains could be lost without increased domestic financing, sustained external support and the integration of NTD services into primary healthcare.

Global Progress Against NTDs

Also read: World Chagas Disease Day: Women Key To Prevent, Eliminate The Fatal Neglected Tropical Disease

The number of people requiring interventions for NTDs fell to 1.41 billion in 2024, a 36% decline since 2010 and a 19% decline since 2020.

Cases of sleeping sickness have dropped by 98% since 1999, while Guinea worm disease recorded just 10 human cases in 2025, its lowest number yet.

Between 2021 and 2025, 31 countries eliminated at least one NTD. Of these, 16 received WHO recognition for the first time. Between January and June 2026, five more countries received recognition: Algeria, Australia, Libya and Tunisia for trachoma, and Chile for leprosy.

By June 2026, 42 countries had eliminated one disease each, 16 had eliminated two, four had eliminated three and one country, Togo, had eliminated four.

India has eliminated three NTDs: Guinea worm disease in 2000, yaws in 2016 and trachoma in 2024.

Why Dengue Remains A Concern

Read More: Dengue Is Spreading Beyond Monsoons And Into New Regions Across India, Says Expert

Despite progress against several NTDs, the report highlights uneven progress, with these diseases continuing to disproportionately affect the world's poorest and most vulnerable communities.

Dengue remains a major concern. Cases of the mosquito-borne disease reached a record 15.1 million in 2024, up from 2.74 million in 2020.

Locally acquired cases were reported across all six WHO regions. The organisation also classified dengue as a Grade 3 emergency, its highest emergency level, in 2024.

The Region of the Americas accounted for most reported cases, with Brazil contributing the largest share of the regional burden.

WHO said climate and environmental change, rapid and often unplanned urbanisation, population movement and the geographical expansion of Aedes mosquitoes are contributing to the spread of dengue.

WHO also warned that the geographical expansion of dengue into previously unaffected populations increases the risk of severe disease from secondary infections, making health system preparedness and the management of severe cases increasingly important.

In 2024, 12,554 deaths were reported across dengue, visceral leishmaniasis and chikungunya, against the 2030 target of 1,291 or fewer annual deaths.

Dengue accounted for 11,827 of these deaths, followed by visceral leishmaniasis (482) and chikungunya (245). Compared with the 2016 baseline of 5,163 deaths, reported deaths from these three diseases increased by 143.2%.

Other NTD Targets Remain Off Track

READ: Milestone In Kala-Azar Treatment: WHO Updates Treatment Guidelines, Recommends Shorter & Safer Regimens

The report also identified several challenges to achieving the 2030 targets. Deaths from vector-borne NTDs have increased, while progress towards yaws eradication remains off track. Only three disease-specific indicators achieved their 2025 milestones.

The WHO's 2021–2030 road map aims to:

  • Reduce by 90% the number of people requiring NTD interventions
  • Reduce NTD-related disability and premature deaths by 75%.
  • Enable 100 countries to eliminate at least one NTD
  • Eradicate Guinea worm disease and yaws

With five years remaining to meet these targets, WHO called for accelerated action, increased domestic financing and the integration of NTD interventions into universal health coverage to protect progress and address persistent gaps.

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Utah Becomes The First US State To Let AI Prescribe Medicines: What Are The Patient Safety Concerns?

Updated Nov 5, 2026 | 09:00 AM IST

SummaryAn AI system will now be able to prescribe acne medication independently to eligible adults in Utah without doctors' oversight.
Utah Becomes The First US State To Let AI Prescribe Medicines: What Are The Patient Safety Concerns?

Credit: AI

Utah has become the first US state to authorise an artificial intelligence (AI) system to issue prescriptions for certain medications, marking a significant development in the use of AI in healthcare.

The pilot programme allows Nolla Health, a healthcare technology startup, to use its AI-powered dermatology app, Nolla Derm, to examine adults with mild-to-moderate acne and recommend prescription treatments without requiring an doctor's and supervision.

The programme is currently limited to adults aged 18 and above in Utah and covers a small list of topical acne medications. However, the initiative is significant as AI systems can eventually issue prescriptions without a doctors reviewing every case beforehand.

The development has also raised questions about whether AI can make decisions that are normally made by licensed medical professionals, especially when a prescription depends on assessing a patient's symptoms, medical history and treatment risks.

How Does Utah's AI Prescription Work?

Patients using Nolla Derm are required to verify their identity, provide informed consent and complete a medical questionnaire. They then submit photographs of their face through the app.

The AI system analyses the images to check acne severity and combines this information with the patient's medical history to determine whether treatment is appropriate.

It can then select from a limited list of topical acne treatments approved by physicians and generate a prescription.

The programme is being introduced in three stages, with different levels of medical supervision.

  • First 100 patients: Two Utah-licensed physicians independently review and approve every AI-generated prescription before it is sent to a pharmacy.
  • Next 400 patients: The AI can issue prescriptions directly and physicians will review cases retrospectively.
  • Subsequent patients: Physicians review at least 10% of prescriptions each month, along with cases involving complications or side effects.

Advancing in stages requires the company to meet safety targets, including at least 95% agreement with physician assessments and no serious adverse events, as well as written approval from the state. Patients can also contact a licensed physician through the app.

Also read: Woman With Epilepsy Dies After Following ChatGPT’s Advice To Stop Medication: Why AI Cannot Replace A Doctor

Patient Safety Concerns

While AI can analyse information quickly, prescribing medication involves more than identifying a condition and selecting a drug. Doctors consider a patient's medical history, allergies, existing medications, and other health conditions. There are several concerns surrounding the use of AI for these decisions.

1. Incorrect diagnosis

An AI system assessing acne through photographs may not always be able to distinguish it from other skin conditions. Some skin disorders require different treatments or deeper medical investigation.

If the system incorrectly classifies a condition as acne, a patient could receive inappropriate medication, which could delay correct diagnosis.

Also read: New AI Tool Uses Facial Photos To Predict Cancer Patients’ Survival Risk

2. Missing important medical details

A prescription may be unsuitable because of a patient's allergies, medical history, pregnancy status or other medications.

Although Nolla Derm collects medical information through a questionnaire, questions remain about whether an automated system can consistently identify important details.

Also read: AI-Created Virus Injected Into A Human For The First Time To Fight Antibiotic Resistance

3. Delayed treatment

Not every skin problem is acne. Some lesions or changes in the skin may require an examination to rule out other conditions, including skin cancer.

If patients rely on an automated assessment instead of seeking medical attention, there is a risk that a condition could be overlooked and its diagnosis could be delayed.

4. Limited ability to detect complications

Patients may experience side effects after starting treatment. An AI system may not be able to assess these developments as comprehensively as a clinician who can examine the patient, order investigations or modify treatment.

5. Accountability when something goes wrong

Another concern is determining who is responsible if an AI-generated prescription causes harm. The Utah pilot includes oversight and malpractice insurance requirements, but the bigger question of accountability remains an important issue.

Doctors Question Whether AI Should Prescribe Without Human Oversight

Also read: AI May Suggest 3 Times More Expensive Medical Tests And Drugs Than Doctors, New Study Finds

The initiative has prompted concerns among medical professionals about how much responsibility AI systems should be given in healthcare. John Whyte, chief executive of the American Medical Association (AMA), has questioned whether AI should independently make medical decisions.

"These tools can play a very effective role, but they shouldn't autonomously be trying to practice medicine, and if they are, then they need to be held to very high standards, just as humans are," he told the Los Angeles Times. "And I don't think they can meet that burden," he added.

Earlier in 2026, Utah authorised another AI pilot involving prescription refills through the healthcare startup Doctronic. The programme attracted criticism from the state's Medical Licensing Board, which raised concerns about allowing AI to handle medication decisions without medical professionals.

Can AI Prescribing Improve Access To Healthcare?

Supporters argue that AI could help address gaps in access to medical care, especially for conditions that are commonly straightforward.

Zach Boyd, director of Utah's Office of Artificial Intelligence Policy, said the programme was designed to encourage healthcare innovation while maintaining safeguards.

"The Nolla Health pilot program represents a significant step forward in leveraging AI to improve healthcare access for Utahns, while maintaining rigorous oversight and safety," he said. "Our office facilitates innovative AI solutions while ensuring that public health and patient safety remain paramount."

Nolla's chief medical adviser, Dr Zaid Fadul, also highlighted the importance of independent oversight.

"The real test for AI in healthcare isn't how smart it is. It's whether someone other than the company can shut it off," he said.

"In Utah, the state can, and physicians can. That's the standard every AI in medicine should meet."

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