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.

End of Article

World’s First Cancer Vaccine By Moderna & Merck Cuts Melanoma Recurrence Risk By 42%, Cancer Spread Risk By 38%

Updated Oct 23, 2026 | 11:03 AM IST

SummaryThe latest trial results of Moderna and Merck's experimental personalised cancer vaccine delivered promising results in preventing cancer recurrence and death.
World’s First Cancer Vaccine By Moderna & Merck Cuts Melanoma Recurrence Risk By 42%, Cancer Spread Risk By 38%

Credit: AI

Pharmaceutical giants Moderna and Merck have been developing a personalised cancer vaccine that differs according to the patient's tumour characteristics.

According to results from a Phase 3 clinical trial, the vaccine has reportedly reduced the risk of melanoma returning or death by 42% and the risk of cancer spreading by 38% when combined with standard immunotherapy.

The findings, reported on October 22, build on evidence that messenger RNA (mRNA) technology could play a pathbreaking role in treating cancer.

The experimental vaccine, intismeran autogene, was tested alongside Keytruda, Merck’s immunotherapy drug, in patients whose melanoma had been surgically removed.

Latest Trial Results

The Phase 3 INTerpath-001 trial was based on 1,137 patients with high-risk stage IIB, IIC, III or IV melanoma who had undergone surgical removal of their cancer.

Participants received either intismeran autogene alongside Keytruda or Keytruda alone. The researchers compared how effectively the treatments helped prevent the cancer from returning or spreading.

After two years, 82.2% of patients who received the vaccine combination remained cancer-free, compared to 70% of those who received Keytruda alone, according to the trial results.

The combination also reduced the risk of recurrence or death by 42% and the risk of metastasis or death by 38%.

The study achieved its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival.

Also read: Norah O’Donnell’s Skin Cancer Journey: Her Dermatologist Warns Against Tanning Beds & Sunburns

What Is Intismeran Autogene And How Does It Work?

Unlike conventional vaccines that prevent infections, intismeran autogene is a personalised cancer vaccine. It is developed using a sample of the patient’s tumour to identify mutations that distinguish cancer cells from healthy cells.

The treatment uses mRNA to encode up to 34 tumour targets, known as neoantigens. Once administered, these targets help the immune system recognise those targets and generate an immune response against cancer cells.

The vaccine is designed to be used with Keytruda. The vaccine and immunotherapy therefore have complementary roles in the treatment strategy.

Also read: Could A Daily Pill Help Prevent Breast Cancer Recurrence? Roche's Promising Experimental Drug Awaits FDA Approval

What Did Researchers Say?

Professor Georgina Long, the trial’s principal investigator and medical director of Melanoma Institute Australia, said the results are a significant development for treatment after surgery.

“'This is a coalescence of an mRNA platform, personalised, and the use of algorithms and data in a way that we've never seen before. These results show that patients with earlier-stage melanoma can be treated after surgery in a fundamentally new way,” Professor Long said.

The combination’s safety profile was consistent with previous studies, and the companies said no new safety signals were observed in the Phase 3 trial. Detailed findings are being presented at the European Society for Medical Oncology meeting in Madrid.

She added, “Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer,” Long said in the companies’ August announcement of the trial’s positive topline results.

Moderna and Merck have said they will engage with regulators about submitting the treatment for approval. Further FD review will be needed before it can become a treatment option.

End of Article

Could A Daily Pill Help Prevent Breast Cancer Recurrence? Roche's Promising Experimental Drug Awaits FDA Approval

Updated Oct 22, 2026 | 07:00 PM IST

SummaryRoche's promising once-daily breast cancer pill giredestrant has completed all the phases of its trials, delivering promising results. It will find out if it received FDA approval on November 30, 2026.
Could A Daily Pill Help Prevent Breast Cancer Recurrence? Roche's Promising Experimental Drug Awaits FDA Approval

Credit: AI

An experimental daily pill developed by Swiss healthcare company F Hoffmann-La Roche AG has sparked hope for a new treatment option for people with early-stage breast cancer. The drug, giredestrant, reduced the risk of invasive disease recurrence or death by at least 30% compared to standard hormone therapy, according to findings from its Phase 3 trial.

The US Food and Drug Administration (FDA) is expected to share its drug approval verdict by November 30, 2026.

Giredestrant is an experimental once-daily pill designed to block and degrade oestrogen receptors, which can contribute to breast cancer risk.

It is being studied in oestrogen receptor (ER)-positive, HER2-negative breast cancer, a subtype that accounts for the majority of breast cancer diagnoses.

Breast Cancer Drug Giredestrant’s Trial

Also read: Breast Cancer Awareness Month: Advancing A Risk-Informed and Equitable Approach to Breast Cancer Screening in India

The Phase 3 lidERA trial, involving 4,100 people with early-stage ER-positive, HER2-negative breast cancer, compared giredestrant to standard endocrine therapy.

The results showed that giredestrant reduced the risk of disease recurrence or death by 30% relative to standard endocrine therapy.

At three years, 92.4% of participants receiving giredestrant were alive and free of invasive disease, compared to 89.6% of those receiving standard treatment.

Even though the trial met its primary goal, overall survival data was still immature at the time of analysis. Hence, the findings depict an improvement in invasive disease-free survival, not proof that the drug helps people live longer.

Giredestrant was generally well tolerated in the trial. Treatment was discontinued because of adverse events in 5.3% of participants receiving the drug, compared to 8.2% receiving standard endocrine therapy.

Latest Developments In October 2026

Also read: Breast Cancer Awareness Day: Experts Explain Most Overlooked Breast Changes That Can Delay Diagnosis In Men

On October 19, Roche announced that it would present new giredestrant data at the 2026 ESMO Annual Meeting, scheduled for October 23 to 27 in Madrid.

The presentation includes outcomes reported by patients from the lidERA trial. According to Roche, these findings suggest that the promising results in reducing disease recurrence seen with giredestrant was achieved without compromising tolerability or quality of life of the patients.

The company will also present biomarker findings from the evERA trial, which was based on giredestrant combined with everolimus in advanced breast cancer. These are separate settings from using giredestrant alone after surgery for early-stage disease.

Earlier in October, detailed results from the Phase 3 evERA trial were published in The New England Journal of Medicine.

In people with advanced ER-positive, HER2-negative breast cancer, giredestrant combined with everolimus reduced the risk of disease progression or death by 44%.

With 62%, the combination showed even results among participants whose tumours had an ESR1 mutation, compared to standard endocrine therapy combined with everolimus. The FDA has set December 18, 2026, to announce its decision for this combination in certain patients with advanced breast cancer.

The FDA accepted Roche's application for giredestrant as an adjuvant treatment for adults with stage I to III ER-positive, HER2-negative breast cancer under priority review. The decision will be made on November 30, 2026.

If approved, giredestrant’s use will depend on the overall clinical guidance and patient's individual circumstances. According to Bloomberg, the drug is expected to generate up to $15 billion in revenue.

End of Article

World’s First Human Case Of Shamonda Virus Reported In France; Patient Dies: Should People Be Worried?

Updated Oct 22, 2026 | 04:08 PM IST

SummaryFrance has reported the first case of Shamonda virus, a pathogen which previously affected just animals like cattle, sheep, goats, horses and alpacas.
World’s First Human Case Of Shamonda Virus Reported In France; Patient Dies: Should People Be Worried?

Credit: AI

French health authorities have reported the first known human case of Shamonda virus. The infection has only been identified primarily in livestock until now. The patient, who was severely immunocompromised according to reports, died in October while receiving treatment in Lyon. French health authorities have assured that there is no risk of widespread transmission to the general population.

The case, reported on October 22, 2026, has sparked concerns as well as further investigation into the virus's ability to infect humans.

Authorities believe the patient may have gotten infected in eastern France, where Shamonda virus had been detected in animals during spring and summer.

Investigations are in progress to determine how the infection occurred and whether the virus may have caused neurological complications.

Should People Be Worried?

French health authorities say that there is no reason for the general public to panic. This is a single reported human case, and currently there is no evidence that Shamonda virus is spreading from person to person.

French authorities have stated, “No health risk to the general population has been identified to date.”

The case is nevertheless attention-worthy as Shamonda virus had not previously been documented in humans. Scientists, therefore, need more research to understand whether this was a rare case of infection or whether the virus has crossed the animal-human species barrier permanently.

All About Shamonda Virus

Shamonda is an insect-borne virus that belongs to a group called orthobunyaviruses, within the Simbu serogroup. It was first identified in cattle in Nigeria in 1965 and has since been detected sporadically in animals in parts of Africa and Asia.

In 2026, viruses similar to Shamonda viruses were identified in livestock in several European countries, including France, Germany and Switzerland.

The virus is primarily seen in cattle, although infections have also been reported in sheep, goats, horses and alpacas.

In livestock, symptoms may include fever, diarrhoea, lethargy and reduced milk production. Infection during pregnancy may also cause abortions or fetal abnormalities.

The route of infection in the French patient has not been disclosed yet. Investigators suspect exposure may have occurred in an area where the virus was circulating among livestock.

There is currently no evidence that Shamonda virus spreads aggressively between people. The possibility of human infection and the virus's ability to cause disease in humans require further investigation.

The World Organisation for Animal Health has also highlighted the need for continued monitoring because the public health significance of the Shamonda-like viruses in Europe remain incompletely understood.

Prevention Of Zoonotic Diseases

The Shamonda virus case comes amid growing concerns over the rising threat of zoonotic diseases like Ebola, Marburg and Nipah. More than 60% of human pathogens are zoonotic, while nearly 75% of emerging infectious diseases originate in animals.

According to the International Society for Infectious Diseases (ISID), spillover events—where pathogens jump from animals to humans—have tripled since the 1980s, fueled by deforestation, wildlife trade, industrial farming and climate change.

In an interview with HealthandMe, Dr Nivedita Gupta, Scientist and Head of the Communicable Diseases Division at the Indian Council of Medical Research (ICMR), outlined the key measures to reduce the risk of future pandemics.

Dr Gupta stressed that preventing the next pandemic requires a proactive approach built on integrated surveillance, coordinated data sharing, community participation and stronger indigenous research and development.

She said, “I think the first part is that surveillance should be strengthened in all domains, whether it is human surveillance, animal surveillance, wildlife surveillance, as well as environmental surveillance. So, we really need to do integrated surveillance and strengthen all aspects."

The second major priority, she said, is ensuring that surveillance data across sectors is connected.

"If I'm seeing unusual bird or animal deaths, if I'm sitting in human sector, I should also know about it and I should be able to act very timely to understand whether there are any implications on humans and vice versa."

Dr Gupta said community participation is another critical pillar of pandemic preparedness.

"I think we really need massive community sensitization. And community should be our eyes and ears because there are many people who live in remote areas, who live in forest fringes, and they might be seeing many unusual things happening like sudden deaths among animals, carcasses."

End of Article