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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Young Americans Are Developing Kidney Failure Without Usual Risk Factors: What Is CKDu?

Updated Sep 21, 2026 | 09:15 AM IST

SummaryAn alarming number of young outdoor workers in the United States are showing up with kidney failure caused due to uncommon factors.
Young Americans Are Developing Kidney Failure Without Usual Risk Factors: What Is CKDu?

Credit: AI

Doctors in Texas are seeing otherwise healthy young and middle-aged workers getting diagnosed with severe kidney disease and, in some cases, reaching kidney failure without the diabetes, high blood pressure or any other long-standing condition that commonly damage the kidneys.

The condition doctors suspect is chronic kidney disease of unknown etiology, or CKDu, a form of kidney disease that has been documented for decades among agricultural and manual workers in hot regions of Central America, Sri Lanka and India. Recent reports suggest similar cases may be going unrecognised in the US, particularly among vulnerable migrant workers.

What Is CKDu?

CKDu is a condition in which a person's kidney function progressively declines without the usual causes of chronic kidney disease.

Diabetes and high blood pressure are among the biggest causes of kidney disease globally. But CKDu presents differently as it been reported predominantly in relatively young workers who may have neither condition.

The disease can damage the kidney's filtering and tubular structures and gradually reduce its ability to remove waste and regulate fluids and electrolytes.

Currently, there are no specific tests or treatment options to tackle CKDu. Doctors generally investigate and rule out other causes of kidney damage while considering a person's occupation and environmental exposures.

Also read: Dialysis Demystified: When Is It Necessary, How Does It Work And Can It Be Avoided?

Young Workers Are At Risk

Geographical location is one of the strongest clues that helps doctors confirm CKDu diagnosis. In Central America, the disease has been particularly associated with people doing strenuous agricultural work in hot and humid conditions.

Similar concerns have emerged among outdoor workers in Texas, including people working in construction, roofing and other physically demanding jobs.

Repeated heat stress and dehydration are among the leading suspected contributors. When someone repeatedly loses large amounts of fluid through sweating and does not adequately replace it, the kidneys can come under considerable stress.

Researchers are also investigating whether pesticides, contaminated water, heavy metals, infections and frequent use of painkillers like NSAIDs could contribute. However, the definite cause of CKDu still remains unknown.

Also read: Cefepime: Antibiotic Used For Pneumonia, UTI Linked To Higher Death Risk In Adults

CKDu Remains Silent Until Significant Kidney Damage Has Occured

CKDu can be particularly dangerous because people may have few obvious symptoms during the early stages. Many affected workers discover the problem through blood or urine tests rather than because they feel seriously ill.

By the time symptoms like severe fatigue, weakness, nausea, sleep problems or breathlessness develop, kidney function may already be substantially reduced.

A US study based on patients receiving emergency dialysis at a Texas county hospital found that 17% had clinically diagnosed, suspected or possible CKDu-related kidney failure.

Climate Change Could Be Another Contributing Factor

Researchers are increasingly looking into the connection between extreme heat and kidney health. The National Institute of Environmental Health Sciences says CKDu has emerged mainly among agricultural workers in hot, humid regions and notes that rising global temperatures could increase exposure to severe occupational heat stress.

But scientists are still trying to determine exactly how heat, dehydration and other workplace exposures interact to result in last-stage kidney failure. That uncertainty is one reason why CKDu remains such a difficult disease to study.

A 2026 International Society of Nephrology report noted that proposed causes such as heat stress may contribute to kidney injury without necessarily explaining exactly how the disease begins.

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Trump Proposes A New Board That Could Have Veto Power Over 48 Billion NIH Budget & Prevent 'Woke' Research

Updated Sep 21, 2026 | 08:25 AM IST

SummaryUS President Donald Trump wants to seek greater control over how National Institutes of Health allocates funding for research grants.
Trump Proposes A New Board That Could Have Veto Power Over $48 Billion NIH Budget

Credit: X

US President Donald Trump wants his administration to gain greater control over how billions of dollars in biomedical research funding are distributed. He recently proposed new board that could have the power to veto individual grants of National Institutes of Health (NIH).

The proposal, drafted by Budget Director Russell Vought, emerged after a White House meeting was held on September 18, according to the latest reports. The proposed board would include Vought and NIH Director Jay Bhattacharya, whose unanimous agreement will reportedly be required for grants.

The plan is just a proposal and has not yet been formally issued, and details of its structure and authority could change.

Current Process Of Distributing NIH Grants

The NIH financially back research into cancer, heart disease, infectious diseases, neurological disorders and many other serious conditions. Its current grant process relies heavily on scientific peer review, in which experts evaluate applications for scientific merit before funding decisions are made.

NIH says its peer-review system is intended to provide “fair, independent, expert, and timely scientific reviews” and to prevent funding decisions being coloured from inappropriate influence.

At the second stage, advisory councils made up of scientists and public representatives review applications and provide recommendations.

The institute or centre director currently makes the final funding decision, taking those recommendations and other factors into account. The proposed system could introduce another layer of political oversight above that process that could significantly influence how funds are allocated to research.

Also read: Donald Trump Wants Childhood Vaccines Split Into 5 Shots To Prevent Autism: But Is There Evidence?

Trump Administration Opposes Funding For 'Woke' Research

The administration has argued that federal research funding should better reflect its policy priorities and that some previous grants supported research it considers misaligned with those priorities.

At the White House meeting, Vought reportedly criticised the NIH for funding what he described as “woke” initiatives that conflicted with Trump's goals.

The administration has also argued that changes to research funding are needed to improve oversight and ensure taxpayer money supports what it considers scientifically sound and nationally relevant research.

Also read: Trump Nominates Dr Nicole Saphier As Third Surgeon General Pick

What Could The Proposed Board Change?

According to the reports, the board could review NIH grant awards and block funding that does not align with the administration's priorities. That would represent a significant change from a system in which scientific review is central to determining which research proposals are eligible for funding.

The NIH has already undergone changes to its grant process under the Trump administration. Separately, the White House has proposed more rules that would give political authorities greater power over federal grants across government agencies and sideline scientific peer review advisory.

NIH's Stance

The NIH has not confirmed the details of the proposed board. In a statement reported by The New York Times, NIH spokesperson Joshua Pradko said, “N.I.H. remains committed to its mission of funding biomedical research to benefit the health of the American people.”

Responding to reports that Vought wanted to rescind NIH funding, Pradko also said, “There will be no rescissions to N.I.H. grant monies. All N.I.H. grant monies will be spent.”

The NIH is currently dealing with a record number of applications. More than 40,000 grant applications have been received for the January 2027 council round, according to an NIH update issued September 18.

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Not An Abortion Pill Or STI Shield: Why Emergency Contraceptives May Soon Carry New Warnings On Pack

Updated Sep 20, 2026 | 10:00 PM IST

SummaryThe Union Health Ministry has put forth a new proposal stating that emergency contraceptive pills must be sold with certain warnings on the packaging.
Not An Abortion Pill Or STI Shield: Why Emergency Contraceptives May Soon Carry New Warnings On Pack

Credit: AI

Commonly known as the ‘morning-after pill’, emergency contraceptive pills will soon be sold with prominent warnings on packs.

The Union Health Ministry has proposed bringing levonorgestrel 0.75 mg and 1.5 mg emergency contraceptive tablets under Schedule K of the Drugs Rules, 1945, with mandatory warnings on their packaging and package inserts. The draft notification was issued on September 3 and is currently open to public objections and suggestions.

The proposed warnings are intended to make it clear that the pills are meant only for emergency contraception and that they are not a regular contraceptive method.

They will also indicate that they are not abortion pills and do not protect against HIV or other sexually transmitted infections. They would also warn that frequent use can lead to side effects and advise women seeking regular contraception to consult a healthcare professional.

What Do Emergency Pills Actually Do?

Levonorgestrel is a synthetic version of the hormone progesterone. When taken as emergency contraception, it primarily works by delaying or preventing ovulation, meaning it can prevent an egg from being released when sperm are present.

It is intended to be taken after unprotected sex or contraceptive failure, such as a broken condom. The World Health Organization recommends levonorgestrel emergency contraception as a single 1.5 mg dose, or 0.75 mg in two doses 12 hours apart. It works best when taken as soon as possible and can be used within 120 hours of unprotected intercourse.

Crucially, it does not terminate an established pregnancy. That is why it should not be confused with medication used for medical abortion.

Also read: Exclusive With Leading HIV Expert: What's Driving Rising HIV Cases Among India's Youth And How To Prevent It

Emergency Pills Cannot Protect Against STIs

One of the proposed warnings is meant to addresses a common misconception about emergency contraceptive pills prevents pregnancy, not sexually transmitted infections.

It is important to under stand that levonorgestrel does not protect against HIV, syphilis, gonorrhoea, chlamydia or other STIs. Sexually transmitted infections can be prevented by barrier methods like condoms, when used correctly.

The proposed Indian warning specifically states that emergency contraceptive pills “do not offer any protection against HIV or any sexually transmitted infections.”

Also read: 5 Reasons To Get Regular STI Testing If You’re 'Sexually Active'

Reason Behind The Move

The move follows recommendations from the Drugs Technical Advisory Board (DTAB) after an expert review of contraceptive use in India.

Minutes of the 67th Drugs Consultative Committee meeting recorded recommendations for the package warnings stating that levonorgestrel emergency contraceptives should not be used more than twice a month, that they do not protect against HIV or STIs, and that alternative contraception should be considered with a registered medical practitioner.

The latest draft notification also states that frequent use “may lead to side effects” and encourages women to seek medical advice. However, this does not mean emergency contraception is considered inherently unsafe.

The WHO says side effects like nausea, vomiting, fatigue and temporary menstrual changes are generally mild and can be resolved without treatment. It also states that emergency contraceptive pills do not cause any harm to fertility.

The concern is instead about using an emergency method as a substitute for regular contraception. Repeated use can lead to menstrual irregularities and side effects.

The proposal would place levonorgestrel 0.75 mg and 1.5 mg tablets under Schedule K, while retaining their availability without a prescription. The draft is therefore not supposed to make morning-after pills prescription-only.

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