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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US FDA's New Framework Calls For Speeding Up Approvals For Rare Disease Therapies

Updated Feb 24, 2026 | 12:18 PM IST

SummaryThe US FDA's new Plausible Mechanism Framework will drive innovation among drugmakers and offer patients with ultra-rare diseases life-saving treatments that are safe and low-cost.
US FDA's New Framework Calls For Speeding Up Approvals For Rare Disease Therapies

Credit: Canva

The US Food and Drug Administration (FDA) today recommended a new framework for accelerating approvals for the development of individualized therapies for rare and ultra-rare diseases.

The Plausible Mechanism Framework, issued by the FDA's Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, is the first such framework by the regulator in 25 years.

The draft guidance can help drugmakers with cutting-edge personalized treatments for patients with ultra-rare diseases to be used as a basis for FDA approval.

Also Read: Zepbound Outperforms Other Weight Loss Drugs, More Details Inside

The move is expected to drive innovation among drugmakers to develop life-saving treatments for patients with ultra-rare diseases, that are not only safe but also low-cost.

Importantly, with the new framework drugmakers can depend on small, well-controlled studies in cases where traditional randomized controlled trials are not possible due to small patient populations.

“President Donald Trump promised to accelerate cures for American families -- and we are delivering, especially for children with ultra-rare diseases who cannot afford to wait,” said Health and Human Services Secretary Robert F. Kennedy, Jr.

“We are cutting unnecessary red tape, aligning regulation with modern biology, and clearing a path for breakthrough treatments to reach the patients who need them most,” he added.

What Does The Framework Propose

The draft guidance focuses on genome editing and RNA-based therapies such as antisense oligonucleotides.

The therapies must target a specific genetic, cellular, or molecular abnormality.

They must also be designed to correct or modify the underlying cause of the disease. The key criteria for therapies include:

  • Finding the disease-causing abnormality
  • Demonstrating that the therapy targets the root cause or proximate biological pathway
  • Relying on well-characterized natural history data in untreated patients
  • Confirming successful target drugging or editing

“This guidance is a critical step the FDA is taking to tailor our regulatory approach to patients with ultra-rare conditions,” said FDA Commissioner Marty Makary.

“It is our priority to remove barriers and exercise regulatory flexibility to encourage scientific advances and deliver more cures and meaningful treatments for patients suffering from rare diseases,” Makary added.

What Is A Rare Disease

The World Health Organization (WHO) defines a rare disease as an often debilitating, chronic, or degenerative condition affecting 1 or fewer per 1,000 population.

Rare diseases lack of epidemiological data, are at high risk of misdiagnosis, and often also lack of effective treatments.

According to the WHO ICD-11 (International Classification of Diseases), there are over 5,500 rare diseases. It also assigns unique identifiers (URIs) to them for better tracking.

There are estimated to be over 7,000 distinct rare diseases affecting more than 300 million people globally.

Rare Disease Day 2026

The FDA hosted Rare Disease Day, a virtual public meeting, on February 23, in global observance of Rare Disease Week.

The theme “Moving Forward. Looking Ahead. An Event for Patients" explored ways to engage and collaborate with patients and their communities to support and accelerate the development of medical products for rare diseases.

Globally the day is observed on February 28 (February 29 in case of a leap year).

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Zepbound Outperforms Other Weight Loss Drugs, More Details Inside

Updated Feb 24, 2026 | 12:41 PM IST

SummaryA head-to-head trial showed Eli Lilly’s Zepbound produced 25.5% weight loss versus 23% with Novo Nordisk’s CagriSema, missing noninferiority goals. Findings reshape obesity treatment strategies, highlighting real-world effectiveness over hype despite market reactions and upcoming regulatory review.
Zepbound Outperforms Other Weight Loss Drugs, More Details Inside

Credits: Canva

The weight loss drug competition has gotten more serious as a late-stage clinical trial compared two next generation obesity drugs and found Eli Lilly's Zepbound to produce greater result in weight loss than Novo Nordisk's much-anticipated CargiSema. The new Novo Nordisk drug was once projected to redefine the treatment landscape.

As a result, Novo Nordisk's shares have dropped by 16 per cent. However, the outcome is not just significant because of market reaction, but also because these medicines are now shaping how doctors treat obesity, a chronic disease affecting more than one billion people worldwide. The results suggest the next phase of weight-loss therapy will be decided less by hype and more by real world effectiveness.

Also Read: Where You Get Your Rabies Shot Matters: Doctor Explains Why Rabies Vaccines Should Not Be Given In Buttocks

Zepbound Outperforms Other Weight Loss Drugs: What Did The Comparison Reveal?

In the head-to-head study, patients taking CagriSema lost an average of 23 per cent of their body weight after 84 weeks. Participants treated with tirzepatide, sold as Zepbound for obesity and Mounjaro for type 2 diabetes, lost 25.5 per cent.

The gap may appear small but in clinical medicine it matters. The trial’s primary goal was to prove the new Novo Nordisk therapy was at least not inferior to tirzepatide. It failed to meet that benchmark.

Earlier trials had suggested CagriSema might rival or even surpass existing GLP-1 based drugs. However, those studies did not directly compare the medicines against each other. This time the comparison was unavoidable.

Zepbound Outperforms: Why These Drugs Matter Beyond Weight Loss

Modern anti-obesity medicines do more than reduce body fat. Doctors increasingly prescribe them to lower the risk of heart disease, diabetes complications, sleep apnea and fatty liver disease.

Zepbound belongs to a newer class of dual-action hormone therapies. It mimics both GLP-1 and GIP hormones, which regulate appetite, insulin response and metabolism.

CagriSema uses a different strategy. It combines semaglutide, the active ingredient behind earlier blockbuster treatments, with an experimental molecule called cagrilintide that targets hunger signals from another pathway.

Researchers hoped attacking appetite through multiple mechanisms would produce stronger results. The trial showed improvement but not enough to surpass tirzepatide.

Zepbound Outperforms Other Weight Loss Drugs: Did The Trial Design Effect The Outcome?

Novo Nordisk executives said the study’s open label design may have influenced results. Participants knew which drug they were receiving, which could lead to behavioral bias.

Doctors often see adherence improve when patients believe they are taking a proven therapy rather than an experimental one. The company suggested familiarity with tirzepatide may have worked in its favor.

Still, clinical researchers generally consider head-to-head trials the most reliable way to evaluate competing treatments. Even accounting for bias, the data indicates tirzepatide currently delivers slightly greater sustained weight reduction.

Zepbound Outperforms Other Weight Loss Drugs: What Does This Mean For Obesity Treatment Race?

The study highlights a shift happening in obesity care. The first generation of GLP-1 drugs proved weight loss medications could achieve double digit body weight reduction. Now companies are competing over incremental but clinically meaningful gains.

For patients, even a two to three percent difference can affect blood sugar control, blood pressure and long term cardiovascular risk. It can also influence insurance coverage decisions and treatment guidelines.

Novo Nordisk still plans to bring CagriSema to market and has filed for regulatory approval, with a decision expected by late 2026. The company is also studying higher doses and alternative dosing strategies to maximize effectiveness.

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PM Modi In Mann Ki Baat Highlights Growing Awareness Of Organ Donations In India

Updated Feb 23, 2026 | 05:38 PM IST

SummaryIndia has recorded a fourfold surge in organ transplants over the last decade, according to the Ministry of Health and Family Welfare. From less than five thousand in 2013, organ transplants in the country jumped to nearly 20 thousand in 2025.
PM Modi In Mann Ki Baat Highlights Growing Awareness Of Organ Donations In India

Credit: X

Prime Minister Narendra Modi, in his latest episode of Mann Ki Baat, highlighted the growing awareness of organ donations in India.

The Prime Minister lauded people who have undertaken such noble deeds.

According to the latest data from the Ministry of Health and Family Welfare, India has recorded a fourfold surge in organ transplants over the last decade. From less than five thousand in 2013, organ transplants in the country jumped to nearly 20 thousand in 2025.

“Awareness about organ donation is steadily rising in India these days. This is helping those who are in need of it. It is also strengthening medical research in the country. Many organizations and individuals are doing extraordinary work in this direction,” the PM said in the 131st episode of the monthly radio program.

The Prime Minister also paid tributes to 10-month-old Aalin Sherin Abraham, from Kerala, who lost her life in an accident but gave life to five people to become the youngest organ donor in the state.

“There is no greater sorrow for any parent than losing one’s own child. The pain of losing a very young child is deeper. Just a few days ago, we lost Aalin Sherin Abraham, a little innocent girl from Kerala. She left this world at the age of just 10 months.

PM Modi said even amidst "profound pain", Aalin's father, Arun Abraham, and mother, Sherin, decided to donate her organs.

"While on the one hand, they grieved the loss of their daughter, on the other, they were also filled with a spirit of helping others," PM Modi said.

“Aalin Sherin Abraham is no longer with us, but her name has joined the ranks of the nation's youngest organ donors,” he added.

He also mentioned the names of organ recipients -- Lakshmi Devi from Delhi, Gaurang Banerjee from West Bengal, and Ramdev Singh of Sikar, Rajasthan -- who, after receiving the transplants, got a second chance at life.

“You will come across many such inspiring examples. This proves once again that a single noble act can change the lives of countless people. I heartily commend all those who have undertaken such noble deeds,” the Prime Minister said.

Where Does India Stand In Terms Of Organ Transplants?

The National Organ and Tissue Transplant Organization (NOTTO) has recorded an unprecedented progress in organ donation, allocation, and transplantation across the country.

As per the Health Ministry, about 18 per cent of transplants are currently being performed with the organs donated from deceased donors.

In 2025 alone, more than 1,200 families came forward to donate organs of their loved ones after death. Each donor is now also a multiorgan donor, transforming the lives of many.

Since September 2023, more than 4.8 lakh citizens have registered to donate organs and tissues after death through an Aadhaar-based verification system.

Notably, India has also achieved competence in performing difficult organ transplants like the heart, lungs, and pancreas.

The country also leads the world in hand transplants and performs a greater number of hand transplants than any other country.

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