FDA Approves TNKase To Treat Ischemic Strokes In Adults

Updated Mar 7, 2025 | 08:52 AM IST

SummaryIt 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.
Ischemic Stroke

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.

How is TNKase administered?

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.

How Was TNKase approved?

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.

How Common Are These Strokes?

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."

What Are The Symptoms Of Ischemic Strokes?

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.

Other symptoms include:

  • Loss of coordination or clumsiness
  • Blurry vision or double vision
  • Dizziness or vertigo
  • Nausea and vomiting
  • Neck stiffness
  • Mood swings or sudden personality changes
  • Confusion or agitation
  • Seizures
  • Memory loss (amnesia)
  • Headaches which are sudden and severe
  • Passing out or fainting
  • Coma

Are There Any Warning Signs?

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.

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Congo Ebola Outbreak Tops 1,200 Cases; US CDC On Highest Alert

Updated Jun 27, 2026 | 09:35 PM IST

Summary​Projections published by the World Health Organization's Africa regional office in The Lancet Infectious Diseases estimate that the Ebola outbreak could reach about 8,210 cases and 1,420 deaths by mid-September.
Congo Ebola Outbreak Tops 1,200 Cases; US CDC On Highest Alert

Credit: iStock

The Ebola virus disease outbreak in the Democratic Republic of the Congo (DRC) has reached 1,203 confirmed cases, including 321 deaths, according to the latest report from the country's public health authorities.

The report said 148 patients have recovered, while 419 remain in isolation or are receiving hospital care. Health authorities have also identified 265 suspected cases, including 77 deaths.

WHO Warns Fight Is Far From Over

World Health Organization Director-General Tedros Adhanom Ghebreyesus said on X that contact tracing in the DRC is reaching more people and more Ebola patients are recovering and returning home.

However, he warned that the fight is "far from over."

"War and insecurity still slow the response, and mistrust is the real battleground. Win trust, and we win this," he said.

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Nearly 300 Confirmed Patients Unaccounted For

The whereabouts of nearly 300 people who tested positive for Ebola remain unknown, according to Africa's top public health official.

The figures on recoveries, patients in treatment and deaths indicate that 297 confirmed cases are currently unaccounted for.

"This is a concern that we have. Where are these people?" Dr Jean Kaseya, Director General of the Africa Centers for Disease Control andPrevention (Africa CDC), was quoted as saying by The Guardian.

He added that the ongoing humanitarian crisis and conflict in affected areas have left more than one million people living in camps that health workers cannot access.

WHO Projects More Than 8,000 Cases

Read More: Ebola Outbreak: The Unique Symptoms Seen In Patients Infected With Bundibugyo

The current outbreak, caused by the Bundibugyo strain, was officially declared on May 15.

As per projections published by the World Health Organization's Africa regional office in The Lancet Infectious Diseases estimate that the outbreak could reach about 8,210 cases and 1,420 deaths by mid-September.

Clinical Trials Set To Begin

The first trial of drugs that may treat the Bundibugyo virus is expected to begin in the DRC next week. A separate trial testing an antiviral drug to prevent infection among close contacts is scheduled to start a week later.

The outbreak is being driven by the rare Bundibugyo strain, for which there are currently no approved vaccines or treatments.

Scientists working to develop vaccines and therapies say progress is being slowed by the lack of a viable virus sample.

US CDC Raises Response To Highest Level

Meanwhile, the US CDC raised its response to the Ebola outbreak in the Congo to its highest level, but said the risk of the disease spreading in the US remained low.

The move, reserved for the most severe health crises, signals growing concern over the rare strain's rapid spread.

The Centers for Disease Control and Prevention raised its emergency activation to Level 1. It is the most severe designation, which is reserved for critical emergencies and assigns the largest number of staff possible to work the response.

The CDC has also deployed 19 staff members overseas to assist its country teams with the response, Dr Satish Pillai, incident manager for the CDC's Ebola response, said ⁠in a press briefing.

The CDC is also providing financial resources to partners on the ground and has trained 25 local field epidemiologists who can operate in areas that CDC staff cannot access.

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Sepsis: India Joins Global Trial To Screen Newborns For Deadly Drug-Resistant Infections

Updated Jun 26, 2026 | 10:07 PM IST

SummaryThe NeoSep1 trial is expected to enroll 3,000 newborns across Asia and Africa by the end of 2028. ​Along with India, newborns have already been enrolled in Ghana, Kenya, and South Africa. Hospitals in Vietnam, Pakistan, Malaysia, Bangladesh, and Uganda are also expected to join the study.
Sepsis: India Joins Global Trial To Screen Newborns For Deadly Drug-Resistant Infections

Credit: iStock

India has joined the Global Antibiotic Research and Development Partnership (GARDP)-led NeoSep1 clinical trial, a landmark international study evaluating new antibiotic treatments for newborns with drug-resistant sepsis.

Sepsis is the second leading cause of neonatal mortality in India after prematurity and low birth weight, accounting for an estimated 30–40 per cent of all newborn deaths.

The NeoSep1 trial began in India with the first baby enrolled at the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Puducherry, followed by Pt. B.D. Sharma PGIMS in Rohtak. Lokmanya Tilak Municipal Medical College and General Hospital in Mumbai is also expected to begin enrolling newborns soon.

"Every day doctors face the heartbreaking reality of losing babies to sepsis due to lack of safe and effective treatments," said Dr Nishad Plakkal, Principal Investigator of the NeoSep1 trial in India and Associate Dean (Research) and Professor and Head of the Department of Neonatology at JIPMER.

"Having the right antibiotics at the right dose can tip the balance between life and death. This trial offers hope to change that," Plakkal added.

"The trial will give neonatologists new tools, and give babies with sepsis a fighting chance at life," said Sally Ellis, who leads GARDP's Children's Antibiotics Program.

Why Newborns Are At Greater Risk

Also read:US Woman Nearly Died After Brushing Off Sepsis Symptoms As Flu

According to Ellis, newborns are particularly vulnerable to life-threatening sepsis because of their underdeveloped immune systems.

The growing burden of antibiotic resistance in low- and middle-income countries (LMICs) has further worsened the problem by reducing the effectiveness of standard treatments. Studies have reported extremely high resistance to the combination of ampicillin and gentamicin, the antibiotic regimen currently recommended by the World Health Organization for the initial treatment of neonatal sepsis.

"Today, we stand at a tipping point. The antibiotics for newborns that we have relied on for decades are failing against resistant infections in many hospital settings," Ellis said.

What Is The NeoSep1 Trial?

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An estimated 3 million newborns develop sepsis every year. The condition occurs when the body's response to an infection triggers widespread inflammation, potentially leading to tissue damage, organ failure, and death. More than 90% of neonatal sepsis deaths occur in low- and middle-income countries.

The NeoSep1 trial aims to identify safe and effective antibiotic regimens that can reduce deaths caused by drug-resistant neonatal sepsis.

The first phase of the study, conducted in South Africa and Kenya in 2023, validated the appropriate doses of fosfomycin and flomoxef when used in combination with other antibiotics in newborns.

The second phase is using a Personalised Randomised Controlled Trial (PRACTical) design to evaluate and rank multiple antibiotic regimens for newborns with sepsis. The approach is expected to help clinicians choose the most effective treatments based on local patterns of antibiotic resistance while also informing future national and international treatment guidelines.

The NeoSep1 trial is expected to enroll 3,000 newborns across Asia and Africa by the end of 2028.

Along with India, newborns have already been enrolled in Ghana, Kenya, and South Africa. Hospitals in Vietnam, Pakistan, Malaysia, Bangladesh, and Uganda are also expected to join the study.

Warning Signs of Sepsis

Sepsis is a life-threatening reaction to an infection that harms the immune system, tissues, and organs. It can lead to organ failure or death if not treated urgently, according to the Cleveland Clinic.

According to Sepsis Alliance, the acronym TIME can help people recognize potential warning signs of sepsis and seek urgent medical care.

T — Temperature: Body temperature is unusually high or low.

I — Infection: Signs or symptoms of an infection are present.

M — Mental Decline: Confusion, excessive sleepiness, or difficulty waking up.

E — Extremely Ill: Severe pain, extreme discomfort, or shortness of breath.

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Bird Flu Warning: Can The Poultry Industry Of Australia Stop An Outbreak?

Updated Jun 27, 2026 | 11:00 AM IST

SummaryAustralia has confirmed H5N1 bird flu in a second state, prompting tighter biosecurity measures. While commercial poultry farms remain unaffected, authorities are working to prevent outbreaks that could disrupt poultry production and exports.
Bird Flu Warning: Can The Poultry Industry Of Australia Stop An Outbreak?

Credits: Canva

The highly pathogenic H5N1 bird flu virus has now spread to a second Australian state. Less than a week after it was first identified in two seabirds in Western Australia, authorities have confirmed another case in South Australia.

For the general public, the health risk remains low. Experts say people who don't regularly handle infected birds or animals are unlikely to contract the virus. However, Australia's poultry industry is treating the situation with extreme caution.

If the virus were to reach commercial poultry farms, the consequences could be severe. Millions of chickens and other birds could either die from the disease or be culled to stop it from spreading. Such an outbreak could also trigger export restrictions on Australian poultry products and leave farmers facing massive cleanup and recovery costs, even with government assistance.

So far, there is no evidence that H5N1 has entered any commercial poultry farms or Australia's native wild bird populations. The confirmed cases have been limited to wild seabirds.

Even so, poultry producers across the country—particularly in Western Australia and South Australia—are already tightening biosecurity measures to reduce the risk of the virus reaching their flocks.

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Australia's largest poultry producer, Inghams, has restricted access to its Western Australian farms, allowing only essential personnel to enter. The company has also requested permission from the federal government's Chief Veterinary Officer to temporarily move its free-range birds indoors. The aim is to reduce any contact between domestic poultry and wild birds, which are considered the most likely source of infection.

These additional precautions build on the strict biosecurity rules already followed by the poultry industry. Farm visits are kept to a minimum, employees are generally prohibited from keeping backyard chickens or other birds at home, and workers are discouraged from moving between different poultry facilities within a short period. Many farms also require staff to shower before entering, change into company-issued clothing, and follow rigorous hygiene procedures. Measures to keep wild birds away and control rodents and insects are also a standard part of farm management.

The H5N1 strain is particularly deadly for chickens, as well as turkeys and quail. Ducks can also become infected, but they present a different challenge because they may carry and spread the virus without showing obvious signs of illness, making them especially difficult to monitor.

Why Australia Had Remained Bird Flu-Free

Until now, Australia was the only continent where the H5N1 strain, the highly contagious strain of H5 bird flu, had not been detected. Although the virus has circulated across Asia since the 1990s and reached Antarctica in 2024, Australia had remained unaffected.

According to Dr Michelle Wille, ARC Future Fellow at the University of Melbourne, Australia's unique bird migration patterns likely delayed the virus's arrival.

"There are no duck species which routinely migrate between Australia and Asia, nor are there ducks that migrate through Antarctica," Wille wrote in The Conversation.

However, evidence suggests other seabirds—including gulls, skuas and giant petrels—may have helped carry the virus over long distances across Antarctica and subantarctic regions, eventually bringing it closer to Australia, he said.

As per the latest update, Australian scientists believe that the H5 bird flu strain killed more than 13,000 elephant seal pups after infecting a breeding colony on the remote Heard and McDonald Islands, one of Australia's external territories in the sub-Antarctic.

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