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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Bacterial Imbalance In Semen Linked To Male Infertility, Pregnancy Loss: The Lancet

Updated Aug 6, 2026 | 01:00 AM IST

SummaryThe study found that an imbalance in women's gut bacteria was also associated with a lower likelihood of becoming pregnant through fertility treatment, and a longer time to conceive.
Bacterial Imbalance In Semen Linked To Male Infertility, Pregnancy Loss: The Lancet

Credit: iStock

Amid rising global infertility rates, a new study has found that an imbalance in the bacteria present in men's semen may reduce a couple's chances of having a baby and increase the risk of pregnancy loss. Researchers also found that the composition of women's gut bacteria may influence fertility outcomes.

The study, published in The Lancet Obstetrics, Gynaecology & Women's Health, found these associations were particularly evident among couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), as well as those with a history of recurrent pregnancy loss.

Researchers from the University of Copenhagen, Denmark, said the findings point to "imbalances in men's semen and in women's gut bacteria as previously overlooked and potentially treatable risk factors for infertility and recurrent pregnancy loss."

Although the vaginal microbiome has been studied extensively in relation to fertility, the gut and seminal microbiomes have been largely overlooked.

“Incorporation of couple-level microbial assessment might represent a novel approach for targeted therapeutic strategies,” the team said.

Key Findings

The researchers followed 353 women and 191 of their male partners between April 2018 and September 2023. All participants were heterosexual couples undergoing fertility treatment or had experienced recurrent pregnancy loss.

They analyzed bacterial communities in the women's gut and vagina and in the men's semen before tracking pregnancies and birth outcomes. About one in four men had an unhealthy bacterial imbalance, known as dysbiosis, in their semen.

Among couples undergoing IVF or ICSI:

  • 57% of couples in which the male partner had semen dysbiosis had a live birth.
  • In comparison, 85% of couples without the imbalance went on to have a baby.
  • Pregnancy loss was also more common when the male partner had semen dysbiosis, affecting roughly one in five more couples than those without the imbalance.

The researchers also noted that standard semen analysis cannot detect this bacterial imbalance, meaning a man's test results may appear normal even when dysbiosis is present.

Women's Gut Bacteria Also Affected Fertility

The study found that an imbalance in women's gut bacteria was associated with:

  • A lower likelihood of becoming pregnant through fertility treatment.
  • A longer time to conceive.

However, gut bacterial imbalance was not associated with miscarriage, while an imbalance in vaginal bacteria showed no clear link with either infertility or pregnancy loss.

What the Findings Mean

According to the researchers, assessing the microbiome in both men and women could improve infertility evaluation and help identify previously overlooked, potentially treatable factors affecting fertility.

They added that, if confirmed in larger studies, therapies aimed at restoring healthy bacterial balance in semen and the gut could improve fertility outcomes and reduce recurrent pregnancy loss.

What Is Infertility?

Infertility is a disease of the male or female reproductive system, defined as the inability to achieve pregnancy after 12 months or more of regular, unprotected sexual intercourse.

According to the World Health Organization (WHO), one in six people globally experience infertility during their lifetime. The condition can cause significant emotional distress, social stigma and financial hardship, with far-reaching effects on mental and psychosocial well-being.

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AI-Powered Blood Test Detects Liver Cancer Across Diverse Populations, Shows Promise In Earlier Diagnosis

Updated Aug 5, 2026 | 10:00 PM IST

SummaryAccording to a recent study, an AI-based blood test successfully detected liver cancer in people from different geographic and genetic backgrounds.
Changes In Blood Years Before Liver Cancer Diagnosis May Help Identify High Risk People: Study

Credit: AI

An artificial intelligence (AI)-powered blood test has accurately detected liver cancer in patients from two geographically and biologically distinct populations.

It is being considered a breakthrough that can help researchers develop accessible and effective screening for people at high risk of the disease.

About The Study

The study by researchers from Johns Hopkins University, validated an AI-based blood test in 377 participants from Guatemala and Romania, two populations with different genetic backgrounds and major causes of liver disease.

The findings suggest the technology may be effective across diverse populations. It marks an important step in deploying AI in real-world clinical use.

The test is based on DELFI (DNA Evaluation of Fragments for Early Interception), an AI platform that analyses patterns in cell-free DNA fragments circulating in the bloodstream.

Rather than searching for a single mutation, the algorithm detects subtle changes in how DNA is fragmented, which is a sign of cancer.

Also read: Love Diet Coke? A Major New Study Has Some Concerning News For Your Brain

Better Than Conventional Blood Test

Researchers found that when the DELFI blood test was combined with the commonly used liver cancer biomarker alpha-fetoprotein (AFP), along with a patient's age and sex, it detected 89% of liver cancers overall and 79% of early-stage cancers.

This was significantly better and effective than AFP testing alone, which has limited sensitivity for detecting tumours at an early stage.

The study also provided new insights into why the test performs well, showing that DNA fragmentation patterns carry biological signals linked with liver cancer across different patients from different backgrounds.

According to the researchers, this strengthens confidence that the AI technology could be applied beyond a single country or healthcare setting and can be used to improve liver cancer detection systems.

Also read: Bone Marrow Transplant: The Quiet Revolution Transforming India's Fight Against Blood Cancers

How Does The AI Test Work?

Healthy and cancerous cells release tiny fragments of DNA into the bloodstream. The DELFI platform uses AI to examine the size, distribution, and genomic patterns of these fragments.

Instead of looking for a specific mutation, it recognises fragmentation signs that indicate the presence of liver cancer, making it possible to identify the disease using just a simple blood sample.

While the findings are promising, the researchers emphasised that the test is not yet ready for routine clinical use.

Larger human clinical studies will be needed before it can become part of standard liver cancer screening programmes.

If future trials confirm these results, AI-powered blood tests could become a valuable addition to current cancer detection processes, helping doctors detect liver cancer earlier and improving outcomes for people at highest risk.

Also read: WHO Cancer Agency Flags 3 Common Medicines As Carcinogenic: What It Means For Millions Of Patients

Who Is At Risk?

Hepatocellular carcinoma (HCC), the most common type of liver cancer, is often diagnosed only after symptoms develop, reducing the chances of successful treatment.

People living with cirrhosis, chronic hepatitis B or hepatitis C infection, and metabolic dysfunction-associated steatotic liver disease (MASLD) are at particularly high risk of contracting this disease.

The existing screening methods, including ultrasound and AFP testing, can miss early cancers, while access to imaging is limited in many parts of the world.

A blood-based test that performs consistently across diverse populations could help improve screening and identify cancers when they are still treatable.

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GLP-1 Drugs Like Mounjaro, Ozempic Linked To 82 Deaths In UK, 162 In US

Updated Aug 5, 2026 | 06:01 PM IST

SummaryDriven by the rising prevalence of obesity and type 2 diabetes, the use of GLP-1 medications such as Ozempic, Wegovy, Mounjaro and Zepbound has increased dramatically in recent years. The global GLP-1 drug market is estimated to reach $200 billion by 2030.
GLP-1 Drugs Like Mounjaro, Ozempic Linked To 82 Deaths In UK, 162 In US

Credit: iStock

From weight loss and diabetes to cancers and much more, GLP-1 drugs have delivered blockbuster results and transformed treatment for millions of people worldwide.

Clinical data have consistently shown that GLP-1 receptor agonists containing semaglutide and tirzepatide—including Ozempic, Wegovy and Mounjaro—reduce overall mortality as well as the risk of heart-related deaths.

However, reports from the UK and US have linked these medicines to more than 200 deaths. While a direct causal relationship has not been established and millions of people use these medications safely, high-profile inquests and adverse event databases have highlighted reports of deaths in which these drugs were listed as a suspected contributing factor, including cases associated with severe complications, dosing errors, and the use of counterfeit or compounded products.

UK Reports 82 Deaths Linked to GLP-1 Drugs

Data submitted to the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) show a total of 82 deaths associated with glucagon-like peptide-1 (GLP-1) receptor agonists, the class of drugs used to treat obesity and type 2 diabetes, up to January 31, 2025.

The data includes 22 deaths associated with GLP-1 agonists used for weight loss, while 60 deaths were linked to their use in treating type 2 diabetes. As per the MHRA data:

  • 18 deaths were linked to tirzepatide (Mounjaro), including 10 associated with weight loss and eight with type 2 diabetes treatment.
  • 29 deaths werelinked to semaglutide products, including Ozempic, Rybelsus and Wegovy. Of these, four were associated with weight loss and 25 with diabetes treatment.
  • 35 deaths werelinked to liraglutide products, including Saxenda and Victoza.

"The decision to start, continue, or stop treatments should be made jointly by patients and their doctor, based on full consideration of benefits and risks," said Alison Cave, MHRA Chief Safety Officer.

Northern Ireland Reported Two Deaths in 2026

In 2026, the deaths of two people in Northern Ireland potentially linked to Wegovy and Mounjaro injections were also reported to the MHRA.

The two cases are among more than 500 suspected adverse drug reaction reports submitted from Northern Ireland over the past two years related to GLP-1 medications.

US Reported 162 Deaths

In the US, Ozempic and Wegovy have been linked to 162 deaths since 2018, according to reports in the FDA's FAERS (FDA Adverse Event Reporting System) database.

While none of the deaths have been proven to be directly caused by semaglutide injections, the reports indicate the drugs were listed as a factor in the fatalities.

Growing Use of GLP-1 Drugs

Driven by the rising prevalence of obesity and type 2 diabetes, the use of GLP-1 medications such as Ozempic, Wegovy, Mounjaro and Zepbound has increased dramatically in recent years. The global GLP-1 drug market is estimated to reach $200 billion by 2030.

Although each medication has distinct FDA-approved uses, they share four common mechanisms of action:

  • Stimulate insulin release.
  • Reduce blood sugar.
  • Slow digestion.
  • Reduce hunger.

FDA Warning on Unapproved GLP-1 Drugs

In June 2026, the FDA raised concerns about patients and healthcare professionals seeking unapproved versions of GLP-1 receptor agonists, including semaglutide and tirzepatide, for weight loss.

The agency warned that unapproved products do not undergo FDA review for safety, effectiveness or quality before being marketed.

The FDA recommends that:

  • Compounded drugs should only be used when a patient's medical needs cannot be met by an FDA-approved drug.
  • Patients should obtain a prescription from their doctor and fill it at a state-licensed pharmacy.
  • Patients should use the FDA's BeSafeRx campaign resources to safely purchase prescription medicines online.
  • Patients should consult their doctor if they have questions about their medications.
  • Patients should contact the compounder or telehealth platform where they purchased the drug if they have questions about instructions for use or label information.

What Are The Red Flags

The FDA advises consumers to watch for warning signs, including companies that:

  • Claim a compounded drug is the same as an FDA-approved product.
  • Offer medicines at deep discounts or prices that seem too good to be true.
  • Send medicines that look different from previous prescriptions, arrive in damaged packaging or lack instructions for use.
  • Do not require screening and a prescription from a licensed doctor.
  • Do not have a licensed doctor available to answer questions after the medication is received.
  • Have spelling errors on labels or provide incorrect pharmacy addresses.
  • List a pharmacy name on the label that appears to be fraudulent.

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