Credits: Canva
The US Food and Drug Administration has approved TNKase or Tenecteplase, which is a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.
Ischemic strokes happen when a blood clot blocks a blood vessel in your brain. It can cause permanent brain damage and death. If enough brain cells die, you can also lose the abilities or body functions those cells control. They are also the most common types of stroke, with 80% of all strokes being ischemic strokes.
It is delivered as a single five-second intravenous bolus, which is faster than the standard of care Activase or alteplase, which is administered as an intravenous bolus followed by a 60-minute infusion. The manufacturer of TNKase, Genetech said a new 25-mg vial configuration will also be available in the coming months.
The approval came at the backdrop of a study that compared TNKase to Activase in patients with acute ischemic stroke. These patients also presented with a disabling neurological deficit. Results show that TNKase was comparable to Activase in terms of efficacy and safety.
In the United States it self, it affects more than 795,000 people each year and is the leading cause of long-term disability. It is also the fifth leading cause of death. Since brain damage can happen if this progresses rapidly, one needs an immediate, fast-acting medical care.
TNKase thus provide a faster and simpler administration which can be critical for anyone. The chief medical officer and head of global product development at Genetech, Levi Garraway, MD., PhD., said, "Today's approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients."
Some of the most common symptoms include weakness or paralysis on one side of your face and body. You may also feel trouble speaking or have loss of speech, also known as aphasia. You may faced slurred or garbled speaking, also known as dysarthria. Other symptoms include loss of muscle control on one side of your face, or sudden worsening or loss of your senses, including vision, hearing, smell, taste, and touch.
While these are symptoms one has who is prone to this condition. However, often, many may confuse it with other illnesses. It is best to keep an eye out for warning signs. These could be looking out for yourself or your loved one. Note if there is a sudden loss of balance. Look out for sudden vision loss or changes in one or both eyes. Look for a droop on one or both sides of your face, especially when you smile. Raise both arms and see if one arm sags or drops in a way it usually does not. Note for your speech. Are you as fluent? Are you have trouble speaking? If you see any of such signs, start tracking it and talk to your healthcare provider.
Credit: AP Photo
US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has announced food policy reforms as part of efforts to implement President Donald Trump’s Make America Healthy Again (MAHA) initiative.
The proposed measures focus on two areas: greater oversight of food ingredients and establishing a standardized federal definition of ultra-processed foods.
As per Kennedy, “nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children”.
To counter this, transforming the food system is key, he said.
“These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy. President Trump and I promised to Make America Healthy Again, and today we are turning that promise into policy,” Kennedy said.
HHS has proposed a rule that would require manufacturers to notify the US Food and Drug Administration (FDA) when they determine that a substance added to human or animal food is Generally Recognized as Safe (GRAS).
In addition, HHS and the US Department of Agriculture (USDA) have submitted for final review the federal government’s first proposed definition of ultra-processed foods (UPFs).
Acting FDA Commissioner Kyle Diamantas said the measures are intended to increase transparency and strengthen science-based oversight of ingredients entering the food supply.
“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” Diamantas said.
He added that the proposed UPF definition could provide a stronger foundation for future nutrition research.
GRAS stands for Generally Recognized as Safe. It refers to substances that are considered safe by qualified experts for their intended use and are therefore exempt from the standard premarket approval requirements for food additives.
Examples of GRAS ingredients include canola oil, vinegar and spices such as black pepper.
Under the proposed rule, manufacturers would be required to notify the FDA when they conclude that a substance qualifies as GRAS. The agency would also expand its public-facing inventory of submitted GRAS notices.
According to Diamantas, mandatory notifications would help close information gaps and give the FDA greater visibility into substances entering the food supply.
HHS and USDA have submitted for final review the federal government’s first proposed definition of ultra-processed foods.
Research has linked high consumption of UPFs with preventable chronic diseases, including type 2 diabetes and heart disease. However, the absence of a standardized federal definition has made it difficult to maintain consistency in research across federal agencies.
The proposed definition incorporates feedback from thousands of stakeholders, including industry representatives, consumer organizations, researchers and members of the public.
Diamantas said the definition could help “create a stronger foundation for future nutrition research.”
The measures are part of the Trump administration’s Make America Healthy Again Strategy and build on efforts to strengthen nutrition science, improve transparency and modernize oversight of the US food supply.
HHS also encouraged Congress to build on these efforts through legislation aimed at further strengthening the safety of the American food supply.
Credit: iStock
The death toll from Ebola has crossed 2,000 in the Democratic Republic of the Congo (DRC), three months after the outbreak was officially declared in May.
The outbreak has caused 4,381 confirmed cases across five provinces, making it the fastest-growing Ebola outbreak recorded in the Central African country. The response has been complicated by strikes by unpaid health workers, misinformation and cultural practices.
The outbreak is caused by the rare Bundibugyo strain of Ebola, for which there is currently no approved treatment or vaccine.
According to the World Health Organization (WHO), the virus first emerged in the DRC in February, about three months before the outbreak was officially declared in the DRC and neighboring Uganda on May 15.
Some early patients were reportedly treated for malaria or typhoid, which can initially cause fever, weakness, vomiting and diarrhea. Early testing also focused on the more common Zaire strain of Ebola, delaying recognition of the Bundibugyo virus.
By early May, WHO had identified an unusual cluster of severe illness and deaths in the Mongbwalu health zone in Ituri Province. An investigation covering April 15 to May 13 subsequently identified 246 suspected cases and 65 deaths across three health zones.
The response has also been affected by conditions in Ituri, including armed conflict, population displacement and poor road access. Health workers have faced shortages of protective equipment, while some healthcare facilities have been affected by workers' strikes.
A new study published in Nature Medicine suggests that the outbreak began through a zoonotic spillover event, meaning the virus jumped from animals to humans before spreading between people.
Researchers from Congo, Uganda, Belgium and other countries found that the outbreak strain was genetically distinct from Bundibugyo Ebola viruses identified during previous outbreaks in 2007 and 2012.
The findings are consistent with a new animal-to-human transmission event, followed by sustained human-to-human transmission.
The study did not identify the specific animal source. However, Ebola viruses are known to periodically spill over from infected animals into human populations.
Genetic analysis also confirmed that cases detected in Uganda were linked to the outbreak in Congo.
Bundibugyo virus disease (BVD) outbreaks were previously recorded in 2007–2008 in Bundibugyo District, Uganda, and in 2012 in Isiro, DRC.
For the 2026 outbreak, researchers generated 22 viral genomes from samples collected from patients with BVD in the DRC and Uganda.
The genomes formed a well-supported phylogenetic cluster separate from variants associated with the 2007 and 2012 outbreaks. The analysis also showed evidence of sustained human-to-human transmission.
The researchers called for greater decentralized laboratory diagnostic capacity, including pan-Orthoebolavirus testing and genomic sequencing, to improve early detection and control of future outbreaks.
Ebola can jump to humans from infected animals such as bats, monkeys and apes. Transmission can occur through contact with blood, body fluids, excrement or raw meat during hunting and butchering.
Once the virus enters the human population, it can spread from person to person through contact with infected bodily fluids.
Symptoms of Bundibugyo virus disease are similar to those caused by other Ebola viruses and can include:
Credit: AI
What if one blood sample could detect symptoms of multiple cancers at once, while also disclosing which organ may be affected? A new study from UCLA has brought that possibility a step closer to reality.
Researchers have at UCLA have developed a blood test called MethylScan that can detect molecular signals linked to multiple cancers and other diseases by analysing DNA fragments circulating in the bloodstream.
The findings, published in the Proceedings of the National Academy of Sciences, suggest the test could offer a simpler and potentially cheaper way to screen for serious diseases like cancer before their symptoms appear.
A blood test may be able to detect multiple cancers at once due to cell-free DNA (cfDNA). Every day, billions of cells die and release tiny fragments of DNA into the bloodstream. These fragments carry information about where they came from and what is happening in that tissue.
Instead of primarily searching for cancer-causing mutations, MethylScan looks at DNA methylation, a type of chemical tags that regulate how genes behave.
Different organs have distinct methylation patterns, and those patterns can change when cells become cancerous or diseased.
“DNA methylation reflects the health status of a tissue. It’s a very informative signal,” said Dr Wenyuan Li, professor of pathology and laboratory medicine at UCLA.
The researchers also developed a method to filter out the DNA released by normal blood cells, reducing the "background noise” that can make early cancer signals difficult to detect.
The researchers tested MethylScan using blood samples from 1,061 people, including patients with liver, lung, ovarian and stomach cancers, people with liver diseases and healthy participants.
At 98% specificity, the test detected about 63% of cancers across all stages. For early-stage cancers, its sensitivity was around 55%.
The test also showed promise in identifying where an abnormal signal originated. This could help as a positive blood test would still need to be followed by imaging or other diagnostic tests.
“Being able to trace signals back to their source is important because a positive blood test needs to be followed by imaging or other diagnostic procedures directed at the right organ,” Li said.
Also read: Tudriqev: US FDA Approves Replimune's Skin Cancer Drug After Rejecting It Twice
“Early detection is crucial,” said Dr Jasmine Zhou, the study’s senior author. “Survival rates are far higher when cancers are caught before they spread.”
The findings are promising, but larger trials will be needed to establish whether such tests can reliably detect cancers in people who have no symptoms.
Also read: Following A Western Diet? Changes In Your Gut Bacteria Could Increase Colon Cancer Risk
The findings come as another multi-cancer test, Galleri, is designed to detect signals from more than 50 cancers from a single blood sample.
Reuters reported this month that the US FDA plans to convene an advisory panel in September to review its application for approval.
But experts continue to stress that these tests are not replacements for established screening, such as mammograms or colonoscopies.
© 2024 Bennett, Coleman & Company Limited