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.

The US Food and Drug Administration (FDA) is investigating a possible cancer risk linked to Novartis' gene therapy Zolgensma after the Swiss drugmaker reported several cases of tumours in patients who had received the treatment. It included two patients aged less than two years old with spinal muscular atrophy (SMA) in which investigators found evidence linking the tumour to the therapy.

Novartis's SMA Drug Under Investigation For Causing Tumour Growth

Zolgensma is a one-time gene therapy used to treat children under two years of age with spinal muscular atrophy (SMA), a rare genetic disorder that causes progressive muscle weakness. More than 6,000 patients have received the treatment since its approval in 2019.

In a safety update issued on November 6, the FDA said it had received reports of neoplasia, or tumour formation including malignancy, known as insertional oncogenesis. This occurs when genetic material delivered by a gene therapy becomes integrated into a patient's DNA and contributes to abnormal cell growth.

In two cases, molecular analysis of tumour tissue showed that DNA from the therapy's viral vector had integrated into the patients' genomes within the GLI1 gene, which can promote cancer when activated. The FDA said it was also investigating a third tumour linked with GLI1.

The agency said tumours had been found in the central and peripheral nervous systems, spinal and paraspinal regions, and kidney.

Also read: Drug-Resistant Epileptic Seizures Reduce By Over 90% With Experimental Gene Therapy

What Has The FDA Said About The Risk?

The FDA is assessing whether regulatory action is needed and is reviewing whether the long-term safety studies address the risk.

However, it stressed that the benefits of both Zolgensma and Novartis' other SMA gene therapy, Itvisma, continue to outweigh their potential risks for their approved uses.

The two therapies use the same viral vector and genetic material but are administered differently. Zolgensma is given through an intravenous infusion to children under two, while Itvisma is injected into the spinal canal and is approved for adults and children aged two and older. The FDA said no cases of tumour formation had been reported following Itvisma treatment so far.

The risk of tumour formation due to viral DNA integration is already mentioned in Zolgensma's information as a theoretical risk. The FDA said patients receiving either treatment should be monitored for tumour formation.

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

What Novartis Said?

Novartis said the two patients whose tumours showed evidence of vector DNA integration had undergone treatment and continued to be monitored.

In a statement, the company said, “Patient safety is our priority. In each case, we timely and appropriately notified health authorities and will continue to work with them on next steps.”

The company also said it had received nine tumour reports since Zolgensma's approval and that the risk was included in the drug's prescribing information.

The disclosures have raised questions among families and patients about when the information was shared. SMA Europe urged the company to explain what is known, what remains uncertain and what the findings could mean for children who have already received treatment. Novartis did not provide details on where the two new cases were in its statement.

The United States is in the midst of one of the worst measles outbreak. It has reported more than 5,000 measles cases in 2026, marking the highest annual total cases since 1991.

This has raised concerns that the country could lose its measles elimination status after more than 25 years.

Measles Cases In The US Cross 5,000

Also read: EXCLUSIVE: Ex-CDC Vaccine Advisor Says Measles Outbreak Bigger Than Reported, Slams RFK Jr’s ‘No-See Evil’ Approach

According to an update issued on November 6, the US Centers for Disease Control and Prevention (CDC) reported 5,182 confirmed cases as of November 5. This is the first time since 1991 that the annual number of infections has crossed the 5,000 mark.

The latest figure marks an increase of 330 cases from the previous week. The CDC also reported 562 hospitalisations due to measles this year, which accounts for 11% of confirmed cases.

The outbreak has spread across 47 jurisdictions and 43 outbreaks reported so far in 2026. Approximately around 96% of infections have been linked to outbreaks, while 96% of people infected were either unvaccinated or their vaccination status was unknown.

The expanding measles outbreak has sparked concerns about the country's ability to maintain the elimination status it achieved in 2000.

Could The US Lose Its Measles Elimination Status?

Also read: 'It’s The Best-Studied Vaccine In Human History': Former CDC Adviser Busts Common Myths About COVID Vaccines

The US declared measles eliminated in 2000, meaning that the country had stopped continuous transmission of the virus for at least 12 months, but infections could still occur when people brought the virus into the country from abroad. However, recent outbreaks have raised concerns that measles could become endemic again.

According to the CDC, elimination status is determined by the absence of continuous measles transmission in a geographical area for 12 months or longer, supported by an effective disease surveillance system.

The United States is facing a review of its elimination status by the Pan American Health Organization (PAHO), which is expected to assess the country's progress in controlling transmission during its November 2026 meeting.

The review will examine whether the ongoing outbreaks represent sustained transmission of the virus and whether the country continues to meet the criteria for elimination. Losing elimination status would that the country had failed to interrupt sustained transmission of the virus.

The Americas region had already lost its measles elimination status in November 2025 after Canada experienced continuous transmission for at least 12 months.

What Happens If The US Loses Its Elimination Status?

Also read: US Midterms: Where Did Voters Support Abortion Rights And Where Did They Reject Them?

Losing measles elimination status would mark a major setback for public health efforts that successfully interrupted continuous measles transmission in the country in 2000.

It would also signal that the virus is circulating continuously within the population rather than appearing mainly through imported infections that cause outbreaks that get eventually contained.

However, elimination status can be regained if sustained transmission is interrupted and the required criteria are met. Public health experts continue to emphasise the importance of maintaining high vaccination coverage, identifying cases quickly and responding to outbreaks promptly.

Who Is Being Affected By The US Measles Outbreak?

The latest CDC data show that measles is affecting people across different age groups. Adults aged 20 and older accounted for 2,132 cases, followed by 2,104 infections among people aged five to 19. Children younger than five accounted for 908 cases.

The CDC reported four measles deaths in 2026, compared with three during the whole of 2025. However, the CDC's national death count differs from figures reported by individual state health departments because the agency uses National Center for Health Statistics mortality data for its official tally.

Pennsylvania has been among the hardest-hit states, reporting 1,487 cases, 287 hospitalisations and six associated deaths, according to Reuters. The outbreak has also spread to South Carolina and Utah, which reported 670 and 536 cases, respectively.

According to state health department reports, the country has recorded eight measles-related deaths this year: six in Pennsylvania, one in New York and one in Wisconsin. At least four involved children or infants.

Life-threatening bleeding episodes among US infants have risen sharply as more parents refuse the routine vitamin K shot given at birth, two new studies have found.

Published in JAMA and JAMA Pediatrics, the studies found that the proportion of newborns who missed the vitamin K shot more than doubled between 2017 and 2025, reaching 6.8%. These infants were also more likely to experience bleeding, including bleeding in the brain.

Although the studies do not establish causation, the parallel rise in refusals and bleeding episodes is significant, said Dr Steven Woolf, an epidemiologist at Virginia Commonwealth University and lead author of the JAMA Pediatrics study, as reported by NBC News.

"Now we're stepping away from that, and we're seeing the consequences," Woolf said.

Vitamin K shots have been standard newborn care since 1961 and help prevent vitamin K deficiency bleeding (VKDB), a rare but potentially life-threatening condition.

Infant Bleeding Episodes Nearly Quadrupled Since 2017

Woolf and colleagues analysed medical records of more than 11 million infants aged six months and younger between 2017 and 2025.

During this period, the proportion of newborns receiving a vitamin K shot fell from 97.7% to 95%, while vitamin K deficiency bleeding nearly quadrupled.

The researchers identified 5,217 bleeding events during the study period. The rate in 2025 was approximately double that in 2024, Woolf said.

The researchers noted that the increase coincided with declining public trust following the COVID-19 pandemic, growing vaccine hesitancy and parental scepticism about routine newborn interventions.

Vitamin K Refusals More Than Double To 6.8%

A separate JAMA study by Dr Kristan Scott and colleagues analysed medical records of more than 5.2 million US infants born between 2017 and 2025.

The proportion of newborns who missed the vitamin K shot rose from 3.1% in 2017 to 6.8% in 2025. It had reached 5.1% by the end of 2024.

The study also found that infants who did not receive the shot had:

• A 47% higher risk of bleeding during their first six months.
• More than twice the risk of bleeding in the brain.
• More than twice the risk of death associated with a bleeding diagnosis during their birth hospitalisation.

The authors estimated that one additional bleeding event would occur for every 114 newborns who missed the vitamin K shot.

Separately, an analysis of more than one million births by health data company Truveta for Reuters found that vitamin K refusals increased by more than 57% between January and June 2026.

Why Is Vitamin K Important For Newborns?

Vitamin K is a fat-soluble nutrient essential for blood clotting and bone health. Newborns naturally have low levels, leaving them vulnerable to VKDB.

The American Academy of Pediatrics (AAP) has recommended a vitamin K injection for all newborns since 1961.

Without adequate vitamin K, babies can develop spontaneous bleeding, including severe internal bleeding and bleeding in the brain. These episodes can cause permanent brain damage or death.

Importantly, the vitamin K shot is not a vaccine. It is a one-time injection given shortly after birth to protect babies against VKDB.

Breast milk contains relatively little vitamin K. Exclusively breastfed babies who miss the birth injection therefore remain vulnerable to deficiency bleeding.

The researchers also found increased use of oral vitamin K. However, oral doses are less effective than intramuscular injections, particularly in preventing late-onset VKDB, which can occur weeks or months after birth.

Why Are More Parents Refusing Vitamin K Shots?

Vitamin K refusals have risen since the COVID-19 pandemic amid growing parental concerns about vaccines and routine newborn interventions.

Health experts have also raised concerns about declining trust in health authorities and mixed messages surrounding preventive care.

Refusals have accelerated under US Health Secretary Robert F Kennedy Jr, who has questioned vaccine safety and overseen changes to federal childhood vaccination recommendations.

A US Department of Health and Human Services spokesperson said the Centers for Disease Control and Prevention (CDC) continues to recommend vitamin K shots for newborns. However, the department did not say whether the agency would begin tracking refusals or associated bleeding episodes.