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’s First Approved Dengue Vaccine: Takeda’s QDENGA Protects Against All Four Virus Serotypes

Updated Jul 20, 2026 | 03:02 PM IST

SummaryThe Drug Controller General of India (DCGI) has granted market authorization for QDENGA to prevent dengue in individuals aged 4-60 years. According to Takeda, the vaccine can be administered regardless of previous dengue infection, without requiring pre-vaccination testing.
India’s First Approved Dengue Vaccine: Takeda’s QDENGA Protects Against All Four Virus Serotypes

Credit: iStock

Takeda Biopharmaceuticals India today announced that QDENGA (TAK-003) has become the first dengue vaccine to receive approval in India, marking a major milestone in the country's fight against the mosquito-borne disease.

The Drug Controller General of India (DCGI) has granted market authorization for QDENGA to prevent dengue in individuals aged 4-60 years. According to Takeda, it is India's first approved dengue vaccine and can be administered regardless of previous dengue infection, without requiring pre-vaccination testing.

"Since its launch in 2022, QDENGA has been approved in 43 countries, with more than 32 million doses distributed globally. This approval marks an important step forward in strengthening dengue prevention in India," said Dr. Mahender Nayak, Head of Intercontinental Markets.

QDENGA Vaccine: Why The Approval Matters

The approval comes at a critical time as dengue cases in India have risen sharply over the past two decades.

India accounts for nearly one-third of the global dengue burden. In 2025, more than 113,000 dengue cases were officially reported, although modelling studies suggest the true number of infections may run into tens of millions annually due to underreporting.

Rapid urbanization, climate change and widespread mosquito breeding have made dengue a year-round public health concern. Since there is no specific antiviral treatment for dengue, prevention remains the most effective strategy.

"India carries a substantial dengue burden, and all four dengue virus serotypes co-circulate in several regions. QDENGA is designed to protect against all four serotypes regardless of prior exposure," said Dr. Goh Choo Beng, Medical Affairs Head, Southeast Asia & India Cluster.

Also read: Dengue Serotypes Shifting In Young Adults: How India's Indigenous Vaccine Could Help Prevent Severe Disease

QDENGA: Scientific Evidence

The DCGI approval is supported by Takeda's global clinical development programme comprising 19 Phase 1, 2 and 3 clinical trials involving more than 28,000 participants in dengue-endemic and non-endemic regions.

The pivotal Phase III TIDES (DEN-301) study enrolled more than 20,000 participants across eight countries and evaluated the vaccine's long-term safety and effectiveness.

Key findings include:

  • 80.2% vaccine efficacy against virologically confirmed dengue one year after the second dose.
  • 90.4% efficacy against dengue-related hospitalization at 18 months.
  • 84.1% protection against dengue-related hospitalization after 4.5 years.
  • Safety and efficacy data demonstrating protection for up to seven years across all four dengue virus serotypes.

The approval is also supported by an Indian Phase III (DEN-302) trial involving participants aged 4-60 years, which found QDENGA to be safe, well-tolerated and immunogenic in children, adolescents and adults.

Read More: Dengue Is Spreading Beyond Monsoons And Into New Regions Across India, Says Expert

What Is QDENGA?

QDENGA (TAK-003) is a live-attenuated tetravalent dengue vaccine designed to protect against all four dengue virus serotypes.

It is administered as two 0.5 mL subcutaneous doses, given three months apart.

The vaccine is built on a DENV-2 backbone, incorporating structural proteins from DENV-1, DENV-3 and DENV-4 to provide broad immune protection.

The World Health Organization (WHO) recommends QDENGA for use in dengue-endemic settings without the need for pre-vaccination screening. The vaccine is also included in the WHO List of Prequalified Vaccines, allowing procurement through agencies such as UNICEF and PAHO.

The vaccine has been approved in 43 countries across Asia, Latin America and Europe. It is already part of Brazil's National Immunization Program and is available through public immunization programmes in Argentina, Colombia and Indonesia.

Who can take QDENGA?

The vaccine is approved in India for people aged 4-60 years to help prevent dengue disease.

Manufacturing In India

Takeda had partnered with Indian vaccine manufacturer Biological E in 2024 to expand production of QDENGA.

Under the agreement, Biological E plans to manufacture 50 million doses annually, supporting Takeda's goal of producing 100 million doses globally each year by the end of the decade.

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Minimally Invasive Focal Therapy For Prostate Cancer Promises Fewer Side Effects Than Surgery Or Radiotherapy

Updated Jul 20, 2026 | 02:00 PM IST

SummaryA targeted focal therapy can now help prostate cancer patients as it promises same outcomes with fewer side effects than existing treatments.
Minimally Invasive Focal Therapy For Prostate Cancer Promises Fewer Side Effects Than Surgery Or Radiotherapy

Credit: AI

A minimally invasive treatment that targets only cancerous tissue in the prostate may offer the same chance of treating localized prostate cancer as surgery or radiotherapy while causing significantly fewer side effects, according to a major UK study.

The findings suggest that focal therapy, which destroys only the tumor while preserving the healthy parts of the prostate, could become a viable treatment option for carefully selected patients.

It could help reduce common risks like urinary incontinence and erectile dysfunction that follow conventional treatment.

Prostate Cancer Treatment With Fewer Side Effects

The study, presented by University College London (UCL) and collaborating institutions, compared long-term outcomes of men treated with focal therapy against those receiving radical prostatectomy or radiotherapy.

Researchers found that cancer control was comparable across the treatment groups, while men undergoing focal therapy experienced substantially better functional outcomes.

"This study shows that men with localized prostate cancer do not necessarily have to choose between effective cancer treatment and preserving their quality of life," said Professor Caroline Moore, Professor of Urology at University College London.

"Our results demonstrate that focal therapy can control cancer effectively in appropriately selected men while significantly reducing the side effects associated with whole-gland treatments."

Also read: KRAS-Targeted Vaccine Shows Promise In Fighting Pancreatic Cancer, Triggers Strong Immune Response In Early Trial

Unlike surgery, which removes the entire prostate, or radiotherapy, which treats the whole gland, focal therapy targets only the cancer with the help of high-intensity focused ultrasound (HIFU). By sparing healthy tissue and surrounding nerves, the treatment aims to preserve urinary and sexual function.

According to the researchers, the study provides strong evidence that focal therapy can offer outcomes similar to standard treatments in men whose cancer is confined to a specific area of the prostate.

Not Appropriate For Every Patient

Professor Moore cautioned that focal therapy for prostate cancer may not be suitable for every patient. "It is important that men undergo careful assessment with high-quality imaging and biopsy so that we can identify those who are most likely to benefit from this treatment," she said.

The researchers also emphasized that patients receiving focal therapy require ongoing follow-up, including prostate-specific antigen (PSA) testing and imaging, to monitor any recurrence or progression of disease.

Also read: Broadcaster Lauren Laverne Shares 'Smoldering Myeloma' Diagnosis After Cancer Recovery

Jeremy Clarkson's Revelation

The findings have drawn renewed public attention after television presenter Jeremy Clarkson recently disclosed that he underwent treatment for prostate cancer.

Clarkson revealed that he chose a treatment that reduced long-term side effects, raising awareness about prostate cancer, and the importance of early diagnosis.

Prostate cancer is among the most commonly diagnosed cancers in men worldwide. While surgery and radiotherapy remain the standard treatments for localized disease, both can result in complications like urinary leakage, bowel problems and erectile dysfunction that can affect the quality of life.

Experts say the new findings support a growing shift toward more personalized treatment strategies that balance cancer treatment with quality of life.

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India Logs 339 COVID-19 Cases In First Half Of July: What To Know About The RF.5 Omicron Subvariant

Updated Jul 20, 2026 | 03:03 PM IST

SummaryAccording to the Andhra Pradesh government, RF.5 evolved naturally from the Omicron JN.1 lineage through the LF.7 and PY.1.1.1 sublineages. Based on current evidence, there is no indication that RF.5 causes more severe disease than other Omicron subvariants currently in circulation.
India Logs 339 COVID-19 Cases In First Half Of July: What To Know About The RF.5 Omicron Subvariant

Credit: iStock

COVID-19 is seeing a renewed uptick in India, with 339 infections reported between July 1 and July 16, according to the Andhra Pradesh Health Department.

Andhra Pradesh has reported four COVID-related deaths and 19 active cases, prompting heightened surveillance after officials identified the Omicron RF.5 sublineage in infected patients in the state.

The presence of RF.5 sublineage in Andhra was confirmed through genome sequencing of patient samples from YSR Kadapa district at the National Institute of Virology (NIV), Pune.

COVID-19 Cases Reported

According to the Andhra Pradesh Health Department states that reported COVID infections fromJuly 1-16 include:

  • Kerala: 115
  • Karnataka: 64
  • Maharashtra: 43
  • Tamil Nadu: 39
  • Andaman and Nicobar Islands: 18
  • Delhi: 18
  • Rajasthan: 12
  • Other states: Remaining cases
Also read: Healthcare In India No Longer A Privilege, Becoming A Right: PM Modi

What Is Omicron RF.5?

RF.5 is an Omicron sublineage identified through genome sequencing. The World Health Organization (WHO) is monitoring the variant after it was reported in higher numbers in Singapore and other parts of Southeast Asia, prompting Indian health authorities to closely track its spread.

According to the Andhra Pradesh government, RF.5 evolved naturally from the Omicron JN.1 lineage through the LF.7 and PY.1.1.1 sublineages.

Officials said it is not a recombinant variant, meaning it evolved within a single genetic lineage rather than through the combination of two different variants.

Is RF.5 Dangerous? What Are The Key Symptoms?

Based on current evidence, Dr. Vishnuvardhan said there is no indication that RF.5 causes more severe disease than other Omicron subvariants currently in circulation, although continued surveillance remains important.

The symptoms of RF.5 are similar to those seen with other Omicron variants and include:

  • Sore throat
  • Cough
  • Fever
  • Headache
  • Runny or stuffy nose
  • Fatigue
  • Body aches

Key Spike Mutations In RF.5

In a post on X, Dr. Vipin M. Vashishtha, Member of the WHO Vaccine Safety Net (VSN), said RF.5 carries several spike mutations that may influence how the virus behaves:

  • K478E and Q485E: May affect antibody binding.
  • V152I and Q79E: May contribute to immune evasion.
  • N501Y: May increase ACE2 receptor binding.
  • D614G: May increase infectivity.

However, Dr. Vashishtha said these mutations alone should not be considered reliable predictors of disease severity. RF.5 continues to be monitored through WHO genomic surveillance.

Should You Be Concerned?

According to health officials, there is currently no cause for alarm.

  • RF.5 is a naturally evolved descendant of the JN.1 lineage.
  • There is no evidence that it causes more severe illness than other circulating Omicron variants.
  • Its symptoms are similar to those of recent Omicron subvariants.
  • Health authorities will continue genomic surveillance to monitor its spread.

How to Stay Safe

Health officials advise people to:

  • Wear a mask in crowded indoor settings.
  • Wash hands frequently.
  • Ensure good indoor ventilation.
  • Stay up to date with COVID-19 vaccination.

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