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 Expands Vertex's Gene Therapy for Infants With Sickle Cell Disease, Thalassemia

Updated Jul 2, 2026 | 06:39 PM IST

SummaryEarlier, the one-time CRISPR-based gene-editing therapy was approved only for patients aged 12 years and older. The expanded label is expected to make approximately 5,500 additional children in the US eligible for treatment, the company said.
US FDA Expands Vertex's Gene Therapy for Infants With Sickle Cell Disease, Thalassemia

Credit: iStock

The US Food and Drug Administration (FDA) has expanded the approval of Vertex Pharmaceuticals' Casgevy (exagamglogene autotemcel), making it the first gene therapy approved for children as young as 2 years with sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Earlier, the one-time CRISPR-based gene-editing therapy was approved only for patients aged 12 years and older. The expanded label is expected to make approximately 5,500 additional children in the US eligible for treatment, the company said.

Why The Expanded Approval Matters

The FDA said earlier intervention could help prevent irreversible organ damage and improve long-term health outcomes.

“With today’s decision, pediatric patients as young as 2 years of age can now access a critical additional treatment option to treat these debilitating, life-threatening diseases,” said Karim Mikhail, Acting Director of the FDA's Center for Biologics Evaluation and Research (CBER).

"Making this therapy available to younger patients opens a critical window for intervention and gives these children a meaningful chance at a healthier future," added Megha Kaushal, Acting Deputy Director of the FDA's Office of Therapeutic Products.

Also read: Scientific Breakthrough: US Scientists Create First Synthetic Cell That Eats and Reproduces

Clinical Trial Results

The expanded approval is backed by clinical trial data in children aged 5 to under 12 years.

For sickle cell disease:

  • All 8 evaluable patients experienced no severe vaso-occlusive crises (painful episodes) for at least 12 consecutive months within the first two years after treatment.

For transfusion-dependent beta thalassemia:

  • Eight of nine evaluable patients achieved transfusion independence for at least 12 consecutive months.
  • The median duration of transfusion independence was 20.1 months.

What Is Casgevy?

Casgevy is a one-time gene-editing therapy that uses CRISPR technology to modify a patient's own blood stem cells, enabling the body to produce healthier red blood cells.

Also Read: Popular Potato Chips Brand Recalled, Classified Under Highest FDA Risk Level Over Salmonella Contamination

For people with sickle cell disease, it aims to prevent painful vaso-occlusive crises. In beta thalassemia, it can eliminate the need for regular blood transfusions in many patients.

“These disorders carry a heavy burden for children and their families, affecting growth, development, and long-term health in profound ways,” said Kaushal, also a pediatric hematologist. “Grounded in the scientific evidence that earlier treatment reduces the risk of lasting end-organ damage, making this therapy available to younger patients opens a critical window for intervention and gives these children a meaningful chance at a healthier future.”

The FDA granted the expanded approval through its Commissioner's National Priority Voucher program, completing the review in 53 days.

Vertex said it has also submitted applications to expand Casgevy's use in the United Kingdom and Saudi Arabia, where regulatory reviews are currently underway.

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Popular Potato Chips Brand Recalled, Classified Under Highest FDA Risk Level Over Salmonella Contamination

Updated Jul 2, 2026 | 06:40 PM IST

SummaryThe FDA's recent move to classify the recall of a popular snack brand's chips under its highest risk level has sparked concerns over safety in packaged foods
Popular Potato Chips Brand Recalled, Classified Under Highest FDA Risk Level Over Salmonella Contamination

Credit: AI-generated image

A popular snack brand is currently under scrutiny after its multiple products were classified under the US Food and Drug Administration's (FDA) Class I recall. The move came after concerns over its product being contaminated with Salmonella surfaced.

Why Did The Product Get Recalled?

According to the FDA, the recall was initiated in May by Utz Quality Foods LLC after the company found out that a seasoning ingredient containing milk powder, sourced from California Dairies Inc. through a third-party supplier, may have been contaminated with Salmonella.

The recall affects a few varieties of its Zapp's and Dirty’s potato chips, including Zapp's Bayou Blackened Ranch, Big Cheezy, and Salt and Vinegar potato chips, as well as Dirty brand Salt and Vinegar, Maui Onion, and Sour Cream and Onion potato chips.

According to the FDA, Utz said the seasoning batches tested negative before being used in production, but the decision to recall the products was taken as a precautionary measure.

While no illnesses have been reported yet, the FDA's move indicates there is a reasonable probability that consuming these products could result in adverse health consequences and even death.

Also read: Cyclospora Parasite Spreads Across 17 US States: How To Prevent Parasitic Infection

What Does FDA’s Class I Recall Signify?

The FDA uses three categories to classify product recalls based on the level of public health risk. A Class I recall is usually reserved for products that pose the highest risk to consumers.

It is issued when there is a reasonable probability that consumption or use of the product will cause serious health problems or death.

What Is Salmonella & How Serious It Is?

Salmonella infection, known as salmonellosis, usually develops between six hours and six days after consuming contaminated food.

Also read: Doctors Find 38 Parasites In UK Woman’s Brain After Her Trip To India; What Is Neurocysticercosis?

Common symptoms of salmonellosis include:

  • Diarrhea

  • Fever

  • Stomach cramps

  • Nausea

  • Vomiting

  • Headache

Most healthy people recover within four to seven days without targeted treatment. However, it can become severe when the infection enters the bloodstream. Deemed as a medical emergency, this situation prompts urgent attention.

Those with weakened immunity systems, such as young children, older adults, and women who are expecting are at the greatest risk of developing serious complications from salmonellosis. In rare cases, the infection can become life-threatening.

The FDA has advised consumers not to eat the recalled potato chips. It has also said that anyone who has purchased the affected products should either discard them or return them to the place where they bought them for a refund.

The regulatory body has also said that consumers who experience symptoms of salmonellosis after eating the recalled products, especially those at higher risk for complications, should seek medical care immediately.

Although no infection cases linked to the recalled chips have been reported to date, health officials say the recall is intended to prevent potential cases before they occur.

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New UK Guidance Recommends Annual NHS Health Checks for Women With PMOS

Updated Jul 2, 2026 | 02:36 PM IST

Summary​PMOS, until recently known as polycystic ovary syndrome (PCOS), was renamed following an international consensus published in The Lancet. The new name better reflects the condition's endocrine, metabolic and ovarian features.
New UK Guidance Recommends Annual NHS Health Checks for Women With PMOS

Credit: AI generated image

Women diagnosed with polyendocrine metabolic ovarian syndrome (PMOS) should receive an annual NHS health review and be diagnosed earlier to reduce their long-term health risks, according to draft guidance released by the UK's National Institute for Health and Care Excellence (NICE).

The guidance, now open for public consultation, recommends yearly reviews to monitor symptoms, treatment and the risk of developing serious conditions such as type 2 diabetes and cardiovascular disease. Earlier diagnosis, NICE says, could help people access timely care and make lifestyle changes before complications develop.

PMOS, until recently known as polycystic ovary syndrome (PCOS), was renamed following an international consensus published in The Lancet. The new name better reflects the condition's endocrine, metabolic and ovarian features.

What Does The Draft Guideline Recommend?

Also read: PCOS Is Now PMOS: What The Name Change Means For Millions Of Women

NICE recommends that everyone diagnosed with PMOS should be offered an annual review covering:

  • Menstrual irregularities
  • Symptoms such as excess hair growth (hirsutism)
  • Medication use
  • Screening for long-term health risks, including diabetes and cardiovascular disease

The guideline also includes recommendations on fertility treatment, stating that eligible patients should be offered IVF in line with existing NHS fertility guidance. It also addresses the management of common PMOS-related conditions, including acne, hirsutism and obstructive sleep apnea.

Given the increased risk of metabolic and cardiovascular disease in people with PMOS, the guidance directs healthcare professionals to relevant NICE recommendations for managing these conditions.

Earlier Diagnosis A Key Priority

Read More: Teplizumab: UK NHS To Roll Out World-First Drug To Delay Onset Of Type 1 Diabetes

The draft guideline highlights that PMOS remains underdiagnosed despite affecting an estimated one in eight women.

It recommends investigating PMOS in anyone with irregular or absent menstrual cycles alongside signs of excess male hormones, as these are common indicators of the condition.

The guidance covers girls aged over 10, as well as adult women, trans men and non-binary people who are not receiving gender-affirming hormone therapy or surgery.

People with suspected PMOS should be offered blood tests to measure hormone levels and, where appropriate, pelvic ultrasound scans. The guideline also states that PMOS should not be ruled out after menopause and notes that the condition may be more prevalent among women of Black, Asian and mixed ethnic backgrounds.

Marie Anne Ledingham, consultant clinical adviser for women's and reproductive health at NICE, said the guidance is intended to improve consistency of care and ensure people receive appropriate long-term monitoring.

"PMOS is a common but often overlooked condition that can have a major impact on health and well-being. Recommending a simple annual review is an important step towards ensuring people get the ongoing care and monitoring they need," Ledingham said, in a statement.

Mental Health And Fertility Addressed

The draft guidance recognizes that PMOS affects far more than reproductive health. It is associated with an increased risk of depression, anxiety, eating disorders, fatty liver disease, obstructive sleep apnoea, pregnancy complications and fertility problems.

For people planning a pregnancy, NICE recommends advice on achieving and maintaining a healthy weight, balanced nutrition, regular exercise, good sleep and mental wellbeing to improve reproductive outcomes.

The guidance also stresses that eating disorders should not be overlooked or dismissed based solely on a person's weight.

Laser Hair Removal Not Recommended

While the draft guideline includes recommendations to manage hirsutism, it does not support routine NHS funding for laser and light-based hair removal therapies. NICE concluded that these treatments are not cost-effective, estimating they could cost the NHS "up to £100 million annually" in England if routinely funded.

The draft guideline is open for consultation until August 11, 2026, with the final NICE guidance on PMOS expected to be published in December 2026.

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