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.

A tiny infection under a newborn’s fingernail turned out to be an important clue that led doctors to an unexpected and life-threatening diagnosis of an aggressive brain tumour.

Joey Sharp, from Penicuik in Midlothian, Scotland, was just 11 days old when his parents took him back to hospital after he began struggling to feed, losing weight and developing persistent jaundice. He was also showing signs of twitching intermittently.

A Tiny Nail Problem Led Doctors To Look Further

While examining the newborn, doctors noticed what appeared to be a very small infection in one of his fingernails. According to Joey’s mother, Sam Sharp, the abnormality was so tiny that it looked almost like a grain of sand beneath the nail.

But while doctors were investigating the problem, an ultrasound revealed a tumour in Joey’s brain.

The discovery came as Joey’s other symptoms were becoming increasingly concerning. What initially looked like a minor problem with his finger became part of a much larger medical investigation.

Joey was subsequently diagnosed with glioblastoma, an aggressive form of brain cancer.

Also read: BBC News Presenter Maryam Moshiri Reveals Incurable Blood Cancer: What Is Polycythemia Vera?

Why Were Doctors Looking At His Finger?

The nail infection itself was not reported as the cause of the brain tumour. Rather, investigating the unusual finding was part of the baby's broader medical assessment after he returned to hospital with several unexplained symptoms.

In newborns, symptoms can sometimes be difficult to interpret because babies cannot describe what they are experiencing. Problems such as poor feeding, weight loss, jaundice, and abnormal movements can have many possible causes.

In Joey's case, doctors' investigations ultimately led them to perform imaging that uncovered the brain tumour.

The story is therefore less about a nail infection “causing” a brain tumour and more about how an apparently minor physical finding helped doctors continue investigating a very sick newborn until they found the underlying problem.

Also read: FDA Approves New Breast Cancer Treatment That Targets Resistance Before Cancer Progresses

The Newborn Was Diagnosed With Glioblastoma

For Joey, treatment was intensive. He underwent three brain surgeries and nine rounds of chemotherapy. Two operations were performed to remove the tumour, while a third was needed to deal with scar tissue that was preventing medication from controlling his seizures.

At one point, Joey was experiencing more than 30 epileptic seizures a day and required feeding tubes.

What Symptoms Glioblastoma Can Cause In Newborns?

In babies, brain tumours may announce themselves through changes in head growth, feeding, alertness, vomiting or development rather than the classic headaches adults experience. According to reports on congenital glioblastoma, possible signs include:

• Rapidly increasing head size (macrocephaly) is one of the more important clues in infants
• Bulging or tense soft spot (fontanelle) due to increased pressure inside the skull
• Persistent vomiting, particularly when accompanied by other neurological changes
• Unusual sleepiness or lethargy
• Poor feeding or difficulty feeding
• Irritability or unusual changes in behaviour
• Seizures
• Weakness or reduced movement of one side of the body
• Abnormal eye movements or visual problems
• Delayed development
• Poor weight gain

Despite the severity of his illness and the treatment he required as a baby, Joey survived. He also participated in clinical trials designed to help researchers better understand how chemotherapy can be used to treat babies with brain tumours. He is now reported to be cancer-free.

In a world first, an experimental treatment has been administered to a 26-year-old woman, the daughter of American hedge fund manager Bill Ackman, in which mitochondria from her leg were injected into her eyes.

While the treatment did not restore vision, it produced a temporary return of the pupils’ response to light, offering a potentially important finding, according to scientists from the Icahn School of Medicine at Mount Sinai in a paper published as a preprint on Research Square.

The eye study, posted as a preprint on August 10, has not yet undergone peer review. The treatment remains highly experimental and involved only one patient.

“It was my daughter. Mitochondria has amazing potential,” Ackman said in a post on X, adding that the family had seen a sustained benefit from the initial injection, although it was weaker than the immediate response.

Brain Hemorrhage Left Her Unable To See

In February this year, Ackman’s daughter Lucy collapsed in her Brooklyn apartment after suffering a brain hemorrhage, leaving her unable to move, speak or see, the billionaire said in a post on X.

While doctors performed emergency surgery, the injury damaged her optic nerve and left her unable to see. Her pupils also stopped responding to light.

Despite the progress in other areas, Lucy’s vision has remained severely affected.

After receiving emergency approval from the US Food and Drug Administration, doctors at Mount Sinai extracted mitochondria — the energy-producing structures inside cells — from Lucy’s leg muscle and injected them into the fluid of both eyes, according to Nature.

“Over the last six months, she has recovered her cognition – she understands everything including her circumstance – is able to walk a hundred or more steps at a time with assistance, is making progress with sounds, vowels and consonants and the beginnings of speech, but she remains unable to see,” Ackman said.

Mitochondrial Transplant Showed Temporary Visual Response

The researchers reported that Lucy, who had optic nerve damage in both eyes for three months, received one mitochondrial injection in each eye, 24 hours apart.

Importantly, neither eye developed inflammation. Within days of the injections, her pupils began responding to light again — something that had not happened in 45 tests over the previous 71 days.

She also reported seeing shapes and shadows through her left eye.

However, the response faded after about four weeks, and the treatment did not restore normal vision.

“We are working on a method to inject her eyes with more frequency,” Ackman wrote on X.

When Can Mitochondrial Transplants Help?

According to the researchers, mitochondrial transplantation involves delivering healthy, functioning mitochondria into tissue where the mitochondria have been damaged.

The approach has been studied in the human heart and brain, but had not previously been used in the eye.

"To our knowledge, this is the first administration of isolated mitochondria to the human eye. The procedure was performed to the filed specification in both eyes," the researchers said in the paper.

Retinal ganglion cells, which are involved in transmitting visual information from the eye to the brain, depend heavily on mitochondria to produce energy. In studies involving rodents, mitochondria injected into the vitreous — the gel-like substance inside the eye — have been taken up by these cells and improved their survival after optic nerve injury.

In Lucy’s case, the injection of her own mitochondria into the eyes was reported to be safe and was associated with the temporary return of pupillary responses to light. However, it did not restore normal vision, and the visual response faded after about four weeks.

Because the report involves only one patient and has not yet undergone peer review, much more research is needed to determine whether mitochondrial transplantation could eventually become a treatment for optic nerve damage or other forms of vision loss.

The US Food and Drug Administration has approved a new breast cancer treatment that aims to act on signs of treatment resistance before the cancer starts progressing.

The US FDA has granted accelerated approval to Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose tumours develop an ESR1 mutation while being treated with an aromatase inhibitor and a CDK4/6 inhibitor.

All About The New Breast Cancer Treatment

The new approach uses a blood test to detect circulating tumour DNA (ctDNA) carrying an ESR1 mutation. If the mutation is detected, doctors can switch treatment to camizestrant rather than waiting for visible disease progression on scans.

The FDA described this as its first cancer therapy approval guided by detection of a resistance mutation in circulating tumour DNA before imaging shows progression of the disease.

Also read: Have Dense Breasts? What Women Should Know About Their Breast Cancer Risk

What Did The Clinical Trial Find?

The approval was based on results from the Phase III SERENA-6 trial, which included 315 patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.

All participants were receiving an aromatase inhibitor plus a CDK4/6 inhibitor as their initial endocrine based treatment and had no evidence of disease progression when an ESR1 mutation was detected through blood testing.

Patients were randomly assigned to either switch to camizestrant while continuing their CDK4/6 inhibitor or continue their existing aromatase inhibitor with the CDK4/6 inhibitor.

Survival period without progression was 16 months with camizestrant compared with 9.2 months with standard treatment. The risk of disease progression or death was reduced by 56% with the camizestrant combination.

Also read: Alcohol-Linked Cancer Deaths Doubled In US: Colorectal Leads In Men, Breast Leads In Women

Importance Of ESR1 Mutations

ESR1 mutations are one way hormone receptor-positive breast cancers can adapt to treatment. According to the FDA, fewer than 5% of patients have an ESR1 mutation when HR-positive metastatic breast cancer is first diagnosed. After disease progression on an aromatase inhibitor, however, the mutation is found in nearly 40% of patients.

This means that detecting the mutation earlier could potentially give doctors a chance to change treatment while the cancer is still controlled.

Dr Kevin Kalinsky, an investigator on SERENA-6, said, "The approach allows doctors to change treatment at an earlier opportunity ahead of disease progression rather than waiting until the cancer becomes harder to treat."

Risks And Limitations

The FDA approval is accelerated, meaning continued approval may depend on confirmatory studies that will verify clinical benefit.

The regulator specifically noted that it has not yet been established whether intervening when an ESR1 mutation is detected, before radiographic progression, ultimately translates into a meaningful overall survival benefit.

The FDA has simultaneously approved the Guardant360 CDx blood test as a companion diagnostic to identify patients whose tumours carry the relevant ESR1 mutations.

The significance of the approval therefore goes beyond a new drug. It represents a shift toward using molecular clues in the bloodstream to detect treatment resistance and change therapy before cancer progression becomes visible on a scan.