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.

India’s burden of stillbirths may be larger than what existing official numbers suggest. A new study published in The Lancet Regional Health – Southeast Asia estimates that 565,900 babies were stillborn in India in 2023 when stillbirth is counted from 22 weeks of pregnancy onwards. That comes out to be roughly one stillbirth every minute.

But when the count is restricted to 28 weeks or later, the estimate falls to 347,300. That gap of nearly 220,000 stillbirths has become the focus of the study, casting a doubt on the current method of counting and reporting.

Researchers say India’s true burden of stillbirths is being underestimated as many earlier fetal deaths are being left out of the count.

Definition Of Stillbirth Gestational Age

Stillbirth does not have one universal gestational-age definition. The WHO’s ICD-11 definition uses 22 weeks of gestation or more, while India’s routine reporting and several international comparisons have traditionally focused on losses at 28 weeks or later.

Even though the difference may sound like a technical detail, it changes how many deaths are counted and how many get left out of the database.

The new study found that India's stillbirth rate was 25.9 per 1,000 births at 22 weeks or later, and 16.1 per 1,000 when only deaths at 28 weeks or later. In other words, using the latter threshold captured only part of the real picture.

Researchers also found that the burden was not evenly distributed. Stillbirth rates varied more than four-fold between states, from 9.3 per 1,000 births in Mizoram to 38.2 per 1,000 in Uttar Pradesh. Uttar Pradesh and Bihar together accounted for nearly half of India's total estimated stillbirths.

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India’s Numbers May Be Missing More Than Babies

The researchers compared their estimates with India's Sample Registration System (SRS) and found substantial under-reporting. The national late-gestation stillbirth rate from SRS was 2.3 times lower than the GBD estimate.

Earlier research has also highlighted the same problem. An analysis comparing India's National Family Health Survey with SRS found that the NFHS stillbirth rate was 2.6 times higher than the SRS figure between 2016 and 2020.

Researchers have pointed to incomplete reporting, differences in gestational-age cut-offs and confusion between stillbirth and early neonatal death as possible reasons.

The latest Lancet analysis therefore argues that better surveillance is essential, particularly with routine reporting from 22 weeks onwards.

Also read: 22-Year-Old Frozen Embryo Produced A Healthy Baby: Does An Embryo Have An Expiry Date?

What Is Stillbirth?

Stillbirth is not caused by one single condition. Complications related to the placenta, fetal growth, maternal infections, hypertension, diabetes, congenital abnormalities and complications during pregnancy or labour can all contribute.

Maternal anaemia is another risk factor that has been receiving attention lately. A large Indian study published in August 2026, involving nearly 220,000 pregnancies across 10 cohorts, found that moderate and severe maternal anaemia were associated with a higher risk of stillbirth after 28 weeks. The findings are particularly relevant in India, where NFHS-5 data showed that about 52% of pregnant women were anaemic.

The study calls for stronger antenatal care, intrapartum monitoring, emergency obstetric services and strong healthcare systems, along with better data on the causes and risk factors behind stillbirth.

As study author Rakhi Dandona wrote while discussing the research: “every stillbirth deserves to be counted, understood, and learned from.”

India’s medical industry has backed Maharashtra Food and Drugs Administration (FDA) Commissioner Tukaram Mundhe’s concerns about the sharp gap between procurement prices and maximum retail prices (MRPs) of several medical devices and hospital consumables, with patients ultimately bearing the burden.

IV Set: At Rs 11.05, MRP Rs 325

In a post on social media platform X, Mundhe said the most expensive part of a hospital bill may never touch the hospital, but patients bear the brunt as they have the least information to evaluate, compare prices, or seek alternatives.

This is because “a patient admitted for care has no way of knowing whether the price on a medical consumable reflects its actual cost or a markup fixed long before it ever reached the ward," said the IAS officer, who has previously led several food safety enforcement measures in the country.

He flagged the information gap as a core public health issue.

He shared how a survey of hospital consumables in Maharashtra found an IV infusion set with a trade price of Rs 11.05 carrying a printed MRP of Rs 325, a markup of 2,841%. A syringe procured at Rs 6.75 carried an MRP of Rs 57.20, while a catheter procured at Rs 29.41 carried an MRP of Rs 310.

He noted that “the MRP is often fixed upstream by manufacturers and distributors, disconnected from the trade price by a wide, unexplained margin. The result is a system where the party bearing the cost has the least information to evaluate it”.

Also read: High Sugar, Salt Or Fat? India May Mandate Red Hexagon Labels On Food Packs

Experts Call For Scientific Costing

“Piecemeal assessment of pricing will not serve any purpose. Hospitals get reimbursed under CGHS and PMJAY for procedures at below operating cost. We do not look at that. It is time that we carry out a scientific costing exercise on delivery of healthcare,” Dr Girdhar Gyani, AHPI Director, told HealthandMe.

“Patients deserve fair prices, not 2,800% markups, and ethical manufacturers deserve a level playing field and a fair opportunity to provide affordable, fair-priced medical devices,” added Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD).

Maharashtra FDA Flags Regulatory Gap

Mundhe also flagged the structural regulatory gap. He noted that “scheduled medicines are capped under the Drugs (Prices Control) Order, 2013. Most medical devices and consumables are not leaving both the pricing and the information around it almost entirely unmonitored”.

He called on the Department of Pharmaceuticals and the NPPA to “review” these findings and lay down “clear guidelines on the permissible gap between trade procurement price and declared MRP”.

“It's a step toward closing not just a pricing gap, but the information gap patients are left to bear alone”.

Industry Seeks Fair Pricing Policy

Welcoming the timely intervention by Mundhe, AiMeD said it has consistently cautioned that the current regulatory framework under the Drugs (Prices Control) Order, 2013 is inadequate for medical devices.

“Patients, who cannot bargain or choose devices, are left vulnerable to inflated MRPs, while ethical manufacturers and importers are forced to either play within a distorted system or exit the market. This situation penalises both consumers and responsible suppliers, eroding trust and competitiveness”, it said.

AiMeD has long advocated for a Fair Pricing Policy tailored to medical devices, with transparent trade-margin caps based on ex-factory or landed import prices. Such a system would ensure affordability for patients, encourage ethical competition and strengthen the “Make in India” vision.

The US Food and Drug Administration (FDA) today launched a pilot program aimed at speeding up early-stage drug research and reducing delays before potential new medicines enter human trials.

Called the Expedited Investigational New Drug (IND) Pilot, the program is part of the US Department of Health and Human Services’ (HHS) Operation TrailBlazer, launched in June.

The initiative aligns with the Trump Administration’s efforts to accelerate clinical trials and drug research in the US and maintain American leadership in medical innovation, particularly ahead of China.

“The pilot not only pairs industry innovators with top research institutions to accelerate high-quality data being submitted to the FDA, it also tests if the partnership can accelerate what happens after the FDA allows a clinical trial to proceed,” said Acting FDA Commissioner Kyle Diamantas, J.D.

How Will the Pilot Work?

Also read: Robert F. Kennedy Jr. Launches Reforms To Speed Up Early Drug Research In US

The pilot aims to shorten the time between identifying a potential drug and starting a first-in-human clinical trial by pairing drug companies with qualified research institutions (QRIs).

These institutions will provide scientific expertise to support the preparation of Investigational New Drug (IND) applications.

The FDA said first-in-human clinical trials can currently take up to two years to complete in the US. Similar trials are completed faster in China and Australia, raising concerns about America's position in global scientific innovation.

The FDA will accept applications to participate in the pilot until October 30, 2026.

Review of IND Applications

Under the pilot, selected QRIs will support the IND application preparation process. This will allow the FDA to review and accept individual components of an application on a rolling basis during the pre-IND phase, rather than waiting for all components before beginning review.

The approach is intended to help identify and resolve issues with an IND application sooner and reduce the risk of the FDA placing a first-in-human clinical trial on hold during the 30-day IND period.

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The FDA said the goal is to make the path from scientific discovery to first-in-human trials faster, more predictable and more collaborative.

The federal agency said earlier planning and coordination could reduce unnecessary delays between the start of IND preparation and the beginning of first-in-human studies.

“The pilot hopes to utilize the American innovation ecosystem to accelerate the time to first-in-human clinical trials,” said Karim Mikhail, Director of the Center for Biologics Evaluation and Research (CBER).

Who Can Apply?

Drug sponsors and prospective QRIs will apply as a pair, with drug sponsors submitting applications to the FDA.

Applications will be reviewed by FDA scientific experts. The agency expects to select 8–10 Sponsor-QRI pairs for the initial pilot cohort.

READ: Fall Vaccines 2026: US Doctors Issue COVID, Flu And RSV Jab Guidance

What Is Operation TrialBlazer?

While launching Operation TrialBlazer, Robert F. Kennedy Jr., in a Fox News op-ed, said, “America should continue to lead the world in clinical research and medical innovation. Instead, we are losing ground.”

He cited a study showing that China now conducts more early-stage clinical trials than the United States.

In 2025, Chinese companies accounted for nearly half of global pharmaceutical licensing deal activity. “Those trends should concern every American,” Kennedy said, stressing that “the future of medicine should be built in America.”

According to the FDA, Operation TrialBlazer will help shorten development timelines by six to 12 months through a series of measures, including pairing drug developers with qualified academic centers and contract research organizations to prepare first-in-human trial applications.