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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US FDA Announces Recall Of Vitruvias Therapeutics' Thyroid Tablets Over Super Potency

Updated Aug 25, 2026 | 10:36 AM IST

SummaryConsumption of superpotent thyroid tablets can cause hyperthyroidism (overactive thyroid). Elderly people,pregnant women and infants with prolonged use are at high risk.
US FDA Announces Recall of Vitruvias Therapeutics' Thyroid Tablets Over Super Potency

Credit: FDA/iStock

The US FDA has announced a nationwide recall of Vitruvias Therapeutics' Thyroid Tablets USP 30 mg over potential super-potency, which may cause hyperthyroidism (overactive thyroid).

In a recall notice issued on August 24, the company said the affected thyroid tablets, with lot number 504950, were potentially superpotent.

“Consumption of superpotent Thyroid tablets can cause hyperthyroidism (overactive thyroid) including, but not limited to, weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances,” the company said.

Which Thyroid Tablets Have Been Recalled?

The recalled product is:

  • Vitruvias Thyroid Tablets USP 30 mg
  • Lot number: 504950
  • Expiration date: September 30, 2026

The lot was distributed nationwide in the US to Vitruvias Therapeutics’ direct accounts from January 31, 2025, to September 30, 2025.

A total of 3,655 units were released, of which 1,955 were sold during the distribution period.

Who Is At Greater Risk?

The company noted that patient populations at greater risk from superpotent thyroid tablets include

  • elderly people,
  • pregnant women
  • infants.

Excess levels of thyroid hormones in elderly people have been associated with adverse outcomes, particularly affecting cardiac health.

However, Vitruvias Therapeutics said it has not received any reports of adverse events known to be related to this recall.

The company noted that it is proactively notifying wholesalers by email and phone to discontinue distribution of the recalled product and is arranging for the destruction of all recalled products.

What To Do If You Are Taking the Recalled Product?

Patients currently taking Thyroid, USP from Lot 504950 should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

What Is the Thyroid?

The thyroid is a small gland located in the neck, but it plays an important role in the body's activities. It secretes hormones that control metabolism, or the body's ability to convert food into energy.

Thyroid hormones also regulate several other body functions, including heart rate and body temperature.

When the thyroid gland becomes underactive, a condition called hypothyroidism occurs. It causes bodily functions to slow down. Metabolism may also be reduced, leading to changes in a person's well-being.

Hypothyroidism vs Hyperthyroidism

Speaking to HealthandMe, Dr Shruti Kotangale, Consultant Gynaecologist, Obstetrician and Infertility Expert at AIMS Hospital, Dombivli, explained that conditions such as hypothyroidism and hyperthyroidism are commonly seen in women.

Hypothyroidism occurs when the thyroid gland is underactive. Symptoms can include tiredness, weight gain, dry skin, hair fall, constipation, feeling cold, a slow heartbeat and low mood or depression.

Hyperthyroidism occurs when the thyroid gland becomes overactive. Women may experience weight loss, a fast heartbeat, sweating, anxiety, tremors, irritability, frequent bowel movements, and difficulty sleeping.

Women must seek medical attention and manage these symptoms without delay.

Symptoms of Thyroid

Although weight fluctuations are the most common thyroid abnormality, they are typically accompanied by a group of symptoms, including:

  • Fatigue
  • Cognitive changes
  • Gastrointestinal problems
  • Sensitivity to cold
  • Skin and hair changes

How To Diagnose?

Obtaining a proper diagnosis requires two key steps:

Physical examination: This helps determine whether there is swelling or a nodule in the neck.

Blood tests: These may determine levels of:

  • TSH (thyroid-stimulating hormone)
  • T4 and T3
  • Thyroid antibodies, particularly when autoimmune diseases such as Hashimoto's disease or Graves' disease are suspected
Imaging studies such as ultrasound or thyroid scans may also be used to evaluate the shape and structure of the thyroid gland.

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‘Sunscreen Is A Health Essential’: UK Skin Cancer Survivor Urges Govt To Scrap Tax

Updated Aug 25, 2026 | 09:45 AM IST

SummaryJessica Zbinden-Webster, a skin cancer survivor, is campaigning against taxation on sunscreen and sun protection products, arguing that they are essentials, not cosmetics.
‘Sunscreen Is A Health Essential’: UK Skin Cancer Survivor Urges Govt To Scrap Tax

Credit: AI

A UK skin cancer survivor is urging the government to remove VAT from sunscreen, arguing that products used to protect against skin cancer should not be treated as luxury cosmetics.

Jessica Zbinden-Webster, who was diagnosed with skin cancer at just 26, has renewed her campaign to scrap the 20% VAT charged on sunscreen. She said that sunscreen should be considered a health essential rather than a cosmetic product.

Zbinden-Webster's campaign comes as skin cancer remains a growing public health concern in the UK.

UV Radiation Can Damage The Skin

UV radiation can damage the DNA inside skin cells. Repeated or excessive exposure can cause mutations that increase the risk of skin cancer.

Melanoma, the most serious form of skin cancer, can develop when pigment-producing cells become cancerous. Non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma, are also strongly influenced by UV exposure.

Cancer Research UK says up to nine in 10 melanoma cases could be prevented by staying safe in the sun and avoiding sunbeds. It recommends using sunscreen alongside shade and protective clothing.

Also read: Why Flight Attendants, Pilots Face Higher Risk Of Radiation-Linked Cancer Deaths Than Other Occupations?

Sunscreen Is An Essential To Prevent Skin Cancer

The campaign argues that the way sunscreen is taxed sends the wrong message about its role in disease prevention.

Experts agree that removing VAT from SPF 30+ sunscreen could potentially prevent thousands of melanoma cases and save the NHS more than £128 million a year in treatment costs.

Experts also stress that sunscreen should not be viewed as a license to spend long hours in the sun. Cancer Research UK recommends using SPF 30 or higher with good UVA protection, applying it generously and reapplying regularly. It also advises seeking shade, particularly around the middle of the day, and covering exposed skin with clothing and a hat.

The organisation also points out that UV radiation can damage skin even when the weather feels cool or cloudy, because temperature does not determine UV intensity.

Also read: Does Sunscreen Really Raise Skin Cancer Risk? What The 470,000-Person Study Found

About The Campaign

Zbinden-Webster's own experience has made the issue personal. After her cancer diagnosis, she underwent surgery that removed part of her lower eyelid, followed by a skin graft and further procedures. She has since made daily sunscreen use part of her routine and argues that cost should not become a barrier to prevention.

The campaign is now calling on the UK government to reconsider the VAT classification of sunscreen, particularly products with SPF 30 or higher. She said that sunscreen is only one part of sun protection, but making preventive products more affordable could potentially encourage more people to use them consistently.

Sunscreen Rules To Reduce Skin Cancer Risk

Sunscreen can help reduce UV exposure, but it should not be the only line of defence. Cancer Research UK recommends combining sunscreen with shade and protective clothing.

  • Choose SPF 30 or higher: Look for at least SPF 30 for UVB protection and 4 or 5-star UVA protection.
  • Apply generously: Using too little sunscreen can significantly reduce the protection indicated on the label.
  • Reapply regularly: Reapply at least every two hours, and after swimming, sweating or towelling. Even products marketed as “once-a-day” should be reapplied.
  • Don't forget commonly overlooked areas: Cover the ears, neck, hairline, tops of the feet and backs of the hands.
  • Don't rely on sunscreen alone: Seek shade and wear protective clothing, a hat and UV-protective sunglasses when UV levels are high.
  • Check the UV index: Protection becomes particularly important when the UV index is 3 or higher.
  • Cloudy does not mean you can skip sunscreen: UV radiation can still damage skin when the weather is overcast.
  • Don't use sunscreen as a reason to stay longer in the sun: No sunscreen provides 100% protection, and avoiding sunburn remains important.
  • Protect children: Young skin is particularly vulnerable to UV damage, so children should be protected with shade, clothing and sunscreen.
  • Avoid sunbeds: Artificial UV exposure can also damage skin cells and increase skin cancer risk.

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Eli Lilly & Roche's Alzheimer’s Blood Test Gets FDA Clearance: How Does It Work?

Updated Aug 25, 2026 | 08:45 AM IST

SummaryThe US Food and Drug Administration (FDA) recently cleared a new blood test developed by Eli Lilly and Roche for detecting Alzheimer’s disease.
Eli Lilly & Roche's Alzheimer’s Blood Test Gets FDA Clearance: How Does It Work?

Credit: AI

The US Food and Drug Administration (FDA) has approved a new blood test developed by Roche in collaboration with Eli Lilly that can help identify changes in the brain due to Alzheimer’s in people facing cognitive decline.

Called Elecsys pTau217, the test is meant for adults aged 55 and older who have signs and symptoms of cognitive decline. Roche said it is the first FDA-cleared single-biomarker blood test that can both help rule in and rule out amyloid pathology associated with Alzheimer’s disease.

The Test Identifies A Key Alzheimer’s Biomarker

Elecsys pTau217 measures phosphorylated tau 217 (pTau217) in blood. Tau is a protein involved in the structure of nerve cells. In Alzheimer’s disease, abnormal tau changes occur alongside the accumulation of amyloid-beta plaques in the brain.

Elevated pTau217 in blood is associated with the presence of Alzheimer’s-related amyloid pathology. The test categorises results as positive, intermediate or negative, indicating the likelihood of amyloid pathology. An intermediate result may require additional testing.

Could A Blood Test Replace Brain Scans?

The test could make the initial assessment of Alzheimer’s disease significantly easier as it needs just a blood sample, unlike amyloid PET scans or cerebrospinal fluid testing through a lumbar puncture.

Roche said the test is designed to help clinicians decide which patients may need further evaluation, including PET imaging or CSF testing. It is not intended to be used as a stand-alone diagnosis.

Dr Jared R. Brosch, a neurologist at Indiana University Health, said traditional methods can be “costly, invasive and not readily accessible” and that blood biomarkers could expand access to Alzheimer’s evaluation.

He said, "For decades, clinicians have faced significant challenges in accurately diagnosing Alzheimer's disease in its early stages. While PET imaging and cerebrospinal fluid biomarkers can confirm amyloid pathology in patients with cognitive impairment, these approaches may be costly, invasive and not readily accessible for many patients."

Adding further, he said, "Advances in blood-based biomarkers have the potential to transform the diagnostic pathway by expanding access to evaluation for Alzheimer's across a variety of care settings. As these tools become available, clinicians may be able to evaluate more patients earlier in the disease course, improving diagnostic confidence and helping patients and their families make more informed decisions at a critical time."

Also read: Bruce Willis’ Wife Emma Opens Up On ‘Wrestling’ With Guilt Over 50th Birthday

A Significant Milestone In Alzheimer's Testing

Roche said the new test can run on its existing laboratory infrastructure, with more than 4,500 Roche cobas instruments already installed across US clinical laboratories. Lab including Quest Diagnostics and Labcorp are expected to make the test available.

Roche Diagnostics North America President and CEO Dan Malarek said, "FDA clearance of Elecsys pTau217 marks an important milestone in Alzheimer's disease diagnosis and underscores Roche's continued leadership in advancing innovative solutions that can help patients get answers sooner."

He added, "As the first and only FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology, Elecsys pTau217 has the potential to transform how Alzheimer's is assessed across primary and specialty care. This kind of innovation can help bring diagnostic evaluation closer to patients and give clinicians greater confidence in determining the right step in their care."

Also read: Want to Avoid Dementia? Start These 3 Habits In Your Late 40s, Study Suggests

Lilly Neuroscience President Carole Ho, MD, said a timely diagnosis is an important step for families dealing with the uncertainty of Alzheimer’s disease.

Carole said, "For millions of families navigating the uncertainty of Alzheimer's disease, a timely diagnosis is the first and most critical step toward meaningful care."

She added, "Lilly's collaboration with Roche on Elecsys pTau217 was driven by a shared commitment to bringing one blood test into both primary care, where most patients with cognitive complaints are first seen, and specialty care, helping close the gap between symptoms and answers."

Limitations Of The Test

A positive result does not simply mean that a person has dementia. The test assesses the likelihood of amyloid pathology associated with Alzheimer’s disease.

Cognitive symptoms can have several causes, and doctors still need to consider a person's medical history, symptoms, cognitive testing and other investigations.

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