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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India Signs FTA With New Zealand: What This Means For Healthcare And Med Tech Industry | Explained

Updated Apr 27, 2026 | 08:40 PM IST

SummaryThe India and New Zealand FTA will not only strengthen India’s global economic partnerships but also boost strategic opportunities for the medical devices sector, as well as the country's traditional medicine sector.
India Signs FTA With New Zealand: What This Means For Healthcare And Med Tech Industry | Explained

Credit: Ministry of Commerce & Industry

In a landmark deal, India and New Zealand today signed the India- New Zealand Free Trade Agreement (IN- NZ FTA).

The Agreement was signed by Union Minister of Commerce and Industry Piyush Goyal and New Zealand’s Minister for Trade and Investment Todd McClay at Bharat Mandapam, New Delhi.

The FTA will not only strengthen India’s global economic partnerships but also boost strategic opportunities for the medical devices sector, as well as the country's traditional medicine sector.

In a post on social media platform X, Prime Minister Narendra Modi highlighted the agreement’s "role in promoting traditional knowledge systems, including AYUSH, yoga and organic products, positioning them for greater global relevance".

"The FTA broadens its scope to agriculture productivity, organics, services, mobility, Ayush, and pharma access, making the opportunities all-inclusive and future-oriented," added Commerce Secretary Rajesh Agrawal.

What The FTA Brings To India

For the first time, New Zealand has facilitated trade in Ayurveda, yoga, and other traditional medicine services with India. This landmark provision promotes the global recognition of India’s AYUSH systems, supports medical value travel, and encourages collaboration in wellness services, according to an official statement.

It also reinforces India’s position as a global hub for health, wellness, and traditional medicine services. It gives centre stage to India’s AYUSH disciplines (Ayurveda, Yoga & Naturopathy, Unani, Sowa-Rigpa, Siddha, and Homeopathy) alongside Maori Health practices.

India Signs FTA With New Zealand: What This Means For Healthcare And Med Tech Industry | Explained

In a major breakthrough, the FTA streamlines access for pharmaceuticals and medical devices by enabling acceptance of GMP and GCP inspection reports from comparable regulators, including approvals by the US FDA, EMA, UK MHRA, Health Canada, and other comparable regulators.

"These will reduce duplicative inspections, lower compliance costs, and expedite product approvals, thereby facilitating smoother market access and supporting growth of India’s pharmaceutical and medical devices exports to New Zealand," it added.

India Signs FTA With New Zealand: What This Means For Healthcare And Med Tech Industry | Explained

What Are The Industry Leaders Saying?

The experts hailed the India–New Zealand FTA, calling it a strategic opportunity for the medical devices sector.

"For the healthcare and MedTech sector, the agreement is particularly consequential. A dedicated annex on pharmaceuticals and medical devices creates expedited regulatory pathways, with New Zealand agreeing to recognize GMP and GCP inspection reports from the US FDA, the EU’s EMA, and the UK’s MHRA—reducing duplicative compliance burdens and accelerating product approvals for Indian manufacturers," said Pavan Choudary, Chairman, Medical Technology Association of India (MTaI), in a statement.

"A separate annex on health services and traditional medicine opens structured avenues for medical value travel, digital health, and evidence-based AYUSH, positioning India not merely as a goods exporter, but as a global wellness and healthcare services hub," he added.

Rajiv Nath, Forum Coordinator, Association of Indian Medical Devices Industry (AiMeD), also welcomed the India-New Zealand FTA and said that the reduced tariffs and streamlined regulatory cooperation will boost exports.

It will also "enable technology partnerships, and support affordable access to quality devices. The pact enhances competitiveness for Indian manufacturers while ensuring resilient supply chains and mutual recognition standards, strengthening India’s position as a global MedTech hub," Nath added.

However, Choudary cited that there is a significant gap. He cited that the FTA’s regulatory recognition framework does not yet include India’s Central Drugs Standard Control Organization (CDSCO).

"As India’s pharmaceutical and MedTech industry grows in scale, quality, and global reach, the CDSCO is rapidly maturing into a credible, reference-class regulator. Its inclusion in such bilateral recognition frameworks is not a diplomatic nicety; it is a commercial and strategic imperative. Future trade agreements, and indeed revisions to this one, must correct this omission," the expert said.

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India’s Cancer Trends Are Shifting, But Not In The Best Direction: ICMR Report

Updated Apr 27, 2026 | 06:59 PM IST

SummaryThe cancer burden in India is evolving; some of it is reflected in lifestyle changes that are driven by economic growth. Early detection can help bridge the prevention and treatment gap.
cancer trend

Breast cancer cases are on the rise in India, primarily because of lifestyle choices. (Photo credit: AI generated)

A new analysis by researchers at the Indian Council of Medical Research (ICMR) points to a mixed picture when it comes to cancer trends in India. While cases of breast cancer and oral cancer in men have been steadily rising over the years, cervical cancer has seen a sharp decline—one of the few clear positives in the data.

Cancer pattern in India

The study, published in the Journal of Public Health, looked at patterns across G20 countries over roughly two decades. Researchers used a method that helps separate the effects of ageing from broader social and behavioural changes. In simple terms, it allowed them to see whether cancer risk itself is increasing, or if higher numbers are just a result of people living longer.

For India, the rise in certain cancers is difficult to ignore. Breast cancer cases have been increasing by around 1.8 per cent each year, while oral cancer in men has gone up by about 1.2 per cent annually. These trends stand in contrast to several high-income countries, where rates have either slowed or, in some cases, begun to fall.

Why are breast cancer cases on the rise?

The reason why breast cancer cases are surging in India is not surprising - with the shift in lifestyle choices, it is almost a no-brainer. Rising obesity, sedentary lifestyle, smoking and alcohol use are some of the key contributors. Reproductive patterns, too, have changed - women are planning pregnancies later, breastfeeding for short duration and also experiencing early onset of periods. While these factors may appear insignificant individually, they collectively play a huge role in the long run.

Oral cancer in India

Oral cancer tells a different story—one that is closely tied to India’s long-standing tobacco habits. The use of smokeless tobacco and betel quid continues to be widespread, particularly among men. Alcohol adds to the risk. What makes the situation worse is that many cases are picked up late, often when the disease is already advanced. The data also shows a clear age pattern: men and women have similar rates until about 40, after which the numbers for men rise sharply.

If there is one area where India has made real progress, it is cervical cancer. The study found that incidence has been dropping by over 4 per cent each year, one of the steepest declines among the countries analysed. Experts attribute this to better awareness, improved hygiene, and gradual improvements in reproductive health services over time.

This decline offers a useful lesson. It shows that sustained public health efforts can make a difference. The recent rollout of HPV vaccination for adolescent girls could push these numbers down even further in the coming years.

Cancer diagnosis and treatment pattern in India

The ICMR report also highlights a big concern - in developed countries, cancer risk decreases with the new generation because of improved diagnosis and treatment infrastructure. However, in India, the pattern is not evident enough - risk appears high across age groups, but the diagnosis and treatment bit is not well taken care of. Lack of mortality data in India is a key concern, which makes it hard to assess how the rising numbers translate to heightened death risk. The trend is still strong enough to require immediate intervention.

Can India's rising cancer burden be curbed?

Researchers say the response cannot be one-dimensional. Expanding access to screening, especially for breast cancer, is crucial. Tobacco and alcohol control policies need to be enforced more effectively to tackle oral cancer. At the same time, the gains seen in cervical cancer underline the importance of vaccination and organised screening programmes.

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ICU Rules In India Set For Overhaul: SC-Backed Staff, Discharge Norms Likely from Mid-May

Updated Apr 27, 2026 | 01:12 PM IST

Summary​​As per the new draft guidelines, patients who are stable and no longer need critical support will be shifted out of ICUs to wards or other care units.
ICU Rules In India Set For Overhaul: SC-Backed Staff, Discharge Norms Likely from Mid-May

Credit: iStock

India's Supreme Court has revamped guidelines for intensive care units (ICUs) across the country, and the top court has also asked all the states and Union Territories to prepare a “realistic and practical” action plan to implement the guidelines necessary as a minimum standard for intensive care units.

As per the new draft guidelines, set to be implemented from mid-May, patients who are stable and no longer need critical support will be shifted out of ICUs to wards or other care units.

The guidelines, prepared by a three-member court-appointed committee and reviewed by leading medical experts, were endorsed by the apex court as “practical, implementable, and necessary as a minimum standard for an ICU,” The Hindustan Times reported.

A bench of Justices Ahsanuddin Amanullah and R Mahadevan said copies of the guidelines should be shared with all the states and UTs.

“Moving further, as an immediate measure, let all the additional chief secretaries/secretaries … heading the department of health and medical education in the states and the UTs, convene a meeting of all experts involved in this exercise to prepare an action plan for implementation of the guidelines. Such a plan shall be realistic and practical,” the bench said in its order.

What Are The Draft Guidelines?

  • The guidelines prepared by experts, including AIIMS doctor Nitish Naik, Additional Solicitor General Aishwarya Bhati, and advocate Karan Bharioke as amicus curiae, stressed that doctors’ clinical judgment should guide decisions on the level of care for each patient.

  • The guidelines set minimum standards for how ICUs should function. They recommend having one nurse for every two to three patients in basic ICUs, and one nurse per patient in advanced ICUs where patients need multiple organ support, The Times of India reported.

They also call for round-the-clock monitoring by resident doctors working in shifts, under the supervision of specialists with postgraduate qualifications recognized by the National Medical Council.

  • The document lists requirements for equipment such as ventilators, oxygen supply systems, patient transport facilities, and bedside utilities. It also lays down norms for infection control, fire safety, record-keeping, and regular audits, the media reports said.

  • For capacity, the guidelines suggest that a basic ICU should have six to eight beds, which can be expanded to about 12 beds in hospitals handling more critical cases, depending on the services offered.

The SC bench had urged for a meeting of all concerned to discuss and prepare a final common guideline, which shall then be circulated to all states and UTs.

“A final report/blueprint/recommendation shall be prepared, which shall be placed before this court on the next date,” it said, adding that the entire exercise should be completed within three weeks.

“Let the Ministry of Health, Government of India, formally issue the guidelines placed before us today, to the states and UTs concerned by way of an advisory. A copy of it shall also be uploaded on the website of the Ministry of Health, Government of India,” the bench said, while posting the matter for further hearing on May 18.

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