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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PM2.5 Linked To 8.82 Million Global Cancer Cases, Accounts for Largest Share Among Pollutants: Study

Updated Aug 26, 2026 | 12:07 PM IST

SummaryFurther, each 10 microgram per cubic meter increase in PM2.5 was associated with a 17.9 per cent higher risk of kidney cancer and a 21.1 per cent higher risk of bladder cancer.
PM2.5 Linked To 8.82 Million Global Cancer Cases, Accounts For Largest Share Among Pollutants: Study

Credit: AI Image

Particulate matter sized under 2.5 microns or 0.0025 millimeters (PM2.5) accounted for the largest share of air pollution-induced cancer cases worldwide, according to a new study.

The study, published in the journal Nature Health, showed that PM2.5 was attributable to 8.82 million of the 109 million cancer cases identified between 2000 and 2020. PM2.5 exposure was the dominant contributor to cancers of the respiratory, reproductive and endocrine systems.

What Did The Study Find?

Ambient air pollution is known to pose a global threat to public health. Although the carcinogenic potential of fine particulate matter (PM2.5), ozone (O3) and nitrogen dioxide (NO2) is a growing concern, comprehensive global assessments of their cancer risks remain limited.

The study, led by researchers from the Chinese Academy of Sciences, China, evaluated the effects of long-term exposure to PM2.5, O3 and NO2 on cancer incidence and quantified their attributable burdens worldwide, encompassing 109 million cases from 952 locations between 2000 and 2020.

The results identified PM2.5 as the dominant contributor. The researchers found that globally, each 10 microgram per cubic meter increase in PM2.5, ozone and nitrogen dioxide levels was associated with an increased risk of cancer by 16 per cent, 4.23 per cent and 11.7 per cent, respectively.

Exposure to nitrogen dioxide was attributable to 6.67 million incident cases, while exposure to ozone was attributable to about 2.6 million incident cases during the study period. Women were found to be consistently more vulnerable to most malignancies.

PM2.5 Linked to Cancers Beyond the Lungs

The study also showed that PM2.5-related cancer-inducing gene mutations extend beyond the respiratory system, particularly to cancers of the thyroid, esophagus, colon and rectum, and breast.

Further, each 10 microgram per cubic meter increase in PM2.5 was associated with a 17.9 per cent higher risk of kidney cancer and a 21.1 per cent higher risk of bladder cancer.

Biologically, PM2.5 exerts broad cancer-related impacts, possibly due to its small size and its ability to drive multiple processes, including systemic oxidative stress, DNA damage and immune dysregulation, the researchers said.

Study Uses Global Cancer Data

The study uses high-quality, globally representative cancer datasets involving populations from low-, middle- and high-income countries and therefore ensures generalizability of the findings, the researchers said.

"These findings provide critical impetus for public health policy initiatives aimed at mitigating the global cancer burden,” said the researchers in the paper.

Air Pollution and Cancer Risk

According to WHO data, almost all of the global population (99%) breathe air that exceeds WHO guideline limits and contains high levels of pollutants, with low- and middle-income countries suffering from the highest exposures.

In 2016, the International Agency for Research on Cancer (IARC) classified outdoor (ambient) air pollution as a Group 1 carcinogen, primarily linked to lung cancer.

As per an April 2026 study by The Union for International Cancer Control (UICC), the risks associated with air pollution are similar to those caused by smoking tobacco. Exposure to air pollution can lead to cancer, stroke, respiratory and cardiovascular diseases, and other health issues.

Beyond lung cancers, air pollution has been linked to breast, colorectal, liver, kidney, brain, cervical and ovarian cancers, as well as childhood leukaemia.

Studies also suggest that long-term exposure to high levels of PM2.5 may be associated with a 21% increase in the risk of dying from cancer, and new evidence suggests that the risk of dying from air pollution exposure is increased for lung, breast, liver, colorectal and kidney cancers.

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Tivicay: US FDA Approves Drug to Treat HIV In Newborns

Updated Aug 26, 2026 | 10:26 AM IST

SummaryTivicay and Tivicay PD were previously approved for adults and children older than four weeks. Now, Tivicay PD has been approved for newborns from birth up to four weeks of age weighing at least 2 kg, in combination with other antiretroviral agents.
Tivicay: US FDA Approves Drug to Treat HIV in Newborns

Credit: iStock

The US Food and Drug Administration (FDA) has approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in babies.

Developed by ViiV Healthcare, Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.

Now, Tivicay PD has been approved for newborns from birth up to four weeks of age weighing at least 2 kg, in combination with other antiretroviral agents.

How Does Tivicay Work?

Tivicay and Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor used in combination with other antiretroviral agents to treat HIV.

Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration, which is essential for the HIV replication cycle.

Also read: US Measles Outbreak: Pennsylvania Reports First Deaths Of 2026 As Trump Pushes Back On Vaccines

What’s The Evidence For Tivicay PD In Newborns?

The FDA approval was based on data from the IMPAACT 2023 study, in which 48 newborns exposed to HIV-1 and weighing at least 2 kg received Tivicay PD from birth for up to six weeks, in combination with standard-of-care antiretroviral medications to prevent mother-to-child HIV transmission.

The newborns were followed for 16 weeks. Results showed that Tivicay PD drug levels in newborns were similar to those associated with efficacy in adults.

Importantly, the drug’s safety profile in newborns was also similar to that observed in older pediatric and adult patients.

FDA Priority Review

Read More: Reducing Mother-To-Child HIV Transmission To Zero Key To End AIDS In India: Experts

In June, the FDA accepted a supplemental new drug application (sNDA) for Tivicay PD that would extend its use to newborns from birth. The agency granted the application Priority Review with a PDUFA action date of August 25, 2026.

"Early HIV treatment can help shape a child's future, yet newborns have historically had the fewest age-appropriate treatment options," said Jean van Wyk, chief medical officer at ViiV Healthcare, at the time.

Who Should Avoid Tivicay or Tivicay PD?

Patients should not receive Tivicay or Tivicay PD if they have had previous allergic reactions to the drug or if they are also receiving dofetilide.

Serious allergic reactions have been reported. Patients should be monitored for liver damage. Immune reconstitution syndrome has also been reported in patients treated with combination antiretroviral therapy.

Taking Tivicay or Tivicay PD with certain other medications may cause the drug to stop working against HIV or lead to serious side effects. Patients or their caregivers should tell their healthcare provider about all medications they are taking before starting Tivicay or Tivicay PD.

Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable on a milligram-per-milligram basis.

What Is HIV?

HIV (human immunodeficiency virus) attacks the body's immune system, increasing the chances of developing serious infections or cancer. Without treatment, HIV can lead to AIDS (acquired immunodeficiency syndrome).

There is no cure for HIV, but prevention and treatment options are available.

Preventing Mother-to-Child HIV Transmission

Pediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. The latest statistics show there are 1.7 million children living with HIV, and the majority of AIDS-related deaths among children still occur during the first five years of life.

Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment, and poor availability of optimized pediatric formulations of antiretrovirals, according to UNAIDS.

An HIV-positive mother can pass the virus to her baby during pregnancy, labor, delivery, or breastfeeding, but proper medical care lowers this risk to less than 1%.

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Three Deaths In Chinese Gene Therapy Trials Raise Safety Concerns: Experimental Treatments Under Scrutiny

Updated Aug 26, 2026 | 10:00 AM IST

SummaryThe deaths of three participants in a Chinese gene therapy trials has raised new questions about patient safety, transparency and oversight.
Three Deaths In Chinese Gene Therapy Trials Raise Safety Concerns: Experimental Treatments Under Scrutiny

Credit: AI

The deaths of three patients in experimental gene-editing and cell-therapy trials in China, including two children, have raised grave concerns about patient safety, transparency and oversight in the country's clinical-trial system.

The three deaths occurred in separate investigator-initiated trials (IITs), which are studies led by researchers or medical institutions rather than conducted through the conventional drug-development pathway.

The cases have come to light only months after the deaths, prompting US lawmakers to ask the FDA to scrutinise clinical data generated in China more closely.

Three Patients Died In Separate Experimental Trials

One case involved a 6-year-old girl with Snijders Blok-Campeau syndrome, a rare neurodevelopmental disorder. She died seven days after receiving an experimental gene-editing treatment at Xinhua Hospital in Shanghai in May 2025.

Reports said the treatment was delivered into the spinal fluid, and the hospital's ethics board later determined that the death was definitely related to the treatment.

A second death involved a boy with Duchenne muscular dystrophy (DMD) who received HuidaGene Therapeutics' experimental CRISPR-based therapy. He died in August 2025 after developing acute respiratory distress syndrome (ARDS) during a severe immune reaction following a high dose of the viral-vector treatment. The company disclosed the death in August 2026 after questions from reporters.

The third case involved a man in his 50s with scleroderma, who died in March 2026 after receiving RiboX Therapeutics' experimental in-vivo CAR-T therapy.

RiboX had announced FDA clearance to begin testing the treatment in the US shortly before the death became public.

Also read: Early Trial Examines A One-Time Treatment That Could Replace Statins To Manage High Cholesterol: Study

Why Gene Therapy Can Trigger Serious Reactions?

High doses can further increase this risk. In the HuidaGene case, the child developed ARDS during what the company described as a severe immune reaction. Such reactions can cause widespread inflammation and damage organs, making them potentially life-threatening.

Gene editing also carries another category of risk: the treatment is intended to alter genetic material, so researchers must carefully assess whether editing occurs only at the intended target and whether the delivery system itself creates additional risks.

Also read: UK Plans £22 Million Mini Human Organs Project To Cut Down Animal Testing In Science

Bigger Concern Is Trial Oversight

The deaths have attracted particular attention because they occurred in trials initiated by investigator, which have historically offered researchers a faster route to testing experimental therapies.

Unlike conventional clinical trials, these studies have operated under a different regulatory framework in China. Reports have raised concerns about whether independent safety monitoring was adequate in some cases.

For example, the HuidaGene trial did not have an independent data safety monitoring board, according to reporting by STAT. The study enrolled four boys, and the child who died was the fourth participant to receive treatment and received the highest dose administered in the trial.

US Lawmakers Are Calling For Greater Scrutiny

The cases have prompted Representatives John Moolenaar and Ben Cline to ask the FDA to stop accepting Chinese clinical-trial data for US drug applications unless the agency has recently inspected the trial site.

In a letter to Acting FDA Commissioner Kyle Diamantas, the lawmakers said, “American families deserve confidence that the treatments approved in our country are supported by data produced with rigor, ethics, and accountability.”

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