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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Ebola Cases Reach 1,155, Deaths Top 300 in Congo; WHO Warns of 70% Risk of Spread to South Sudan

Updated Jun 26, 2026 | 10:36 AM IST

SummaryThe WHO report said that South Sudan must continue to reinforce infection prevention and control, rapid response capacity, and cross-border surveillance.
Ebola Cases Reach 1,155, Deaths Top 300 in Congo; WHO Warns of 70% Risk of Spread to South Sudan

Credit: iStock

The Ebola outbreak in the Democratic Republic of Congo continues to worsen, with cases rising to 1,155 and deaths climbing to 304, as per the latest government data.

The figures represent the total confirmed cases as of June 24, according to a situation report which documented 37 new cases and five new deaths in the previous 24 hours. Ituri, North Kivu and South Kivu remain the most affected provinces in Congo.

Experimental treatments

Also read: Ebola Outbreak: The Unique Symptoms Seen In Patients Infected With Bundibugyo

The US is now providing doses of an experimental Ebola treatment developed by Mapp Biopharmaceutical for clinical trials in Congo.

The experimental therapy, known as MBP134, was developed by San Diego-based Mapp Biopharmaceutical. While the US had previously kept its stockpile for potential use in exposed American citizens, it is now making doses available to support clinical research in Congo. This is the first time Washington has publicly committed stockpiled supplies of the treatment for a broader international trial.

According to the World Health Organization, researchers will test MBP134 both on its own and alongside the antiviral drug remdesivir, marketed as Veklury. Remdesivir became widely known during the COVID-19 pandemic and is being evaluated to see whether it can improve outcomes when combined with the antibody treatment.

Ebola: Scientists Lack Access To Virus Samples

The ongoing outbreak is being driven by the rare Bundibugyo strain, for which no approved vaccine or treatment exists. However, scientists racing to develop vaccines and therapies are hampered by the lack of a viable sample of the virus.

“There’s nothing like having the authentic isolate,” said Thomas Geisbert, Professor of microbiology and immunology at the University of Texas Medical Branch in Galveston, who helped develop previous Ebola vaccines, Bloomberg reported.

“Despite so many cases, the global scientific community has not obtained a clinical sample to isolate the virus for the needed animal challenge studies,” added Jennifer Serwanga, head of immunology at the Uganda Virus Research Institute, the report said.

Ebola: WHO Warns Spread to South Sudan

Further, as per a new WHO modelling study published in The Lancet, the growing Congo Ebola outbreak, which has already spread to Uganda, has a 70 per cent chance of reaching South Sudan soon.

The study combined epidemic modelling with spillover estimation to quantify regional risks associated with the 2026 Ituri outbreak using laboratory-confirmed case data from WHO Situation Reports (33 cases as of May 18, 2026, to 598 cases as of June 8, 2026), with projections extending 12 weeks from May 18 to Aug. 10, 2026. It also integrates operational preparedness considerations relevant for neighboring countries.

The report showed that even with the intensified response within DR Congo, uncertainty remains around reported case numbers due to the low rate of contact tracing.

“Sustained control nonetheless remains the primary determinant of regional risk: importation into Uganda is already established, and South Sudan must continue to reinforce infection prevention and control, rapid response capacity, and cross-border surveillance under International Health Regulations 2005,” said researchers from the WHO Regional Office for Africa, Nairobi, Kenya.

The report called for:

  1. Enhanced surveillance at formal and informal points of entry to detect suspected cases early and prevent silent transmission.
  2. Strengthen infection prevention and control (IPC) measures in front-line health facilities to reduce nosocomial transmission and protect health-care workers.
  3. Train, equip, and pre-position rapid response teams for immediate deployment.

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After COVID, The US Is Turning To The Same Organization To Fight Ebola In DR Congo

Updated Jun 25, 2026 | 10:00 PM IST

SummaryThe U.S. is supplying experimental Ebola drug MBP134 for clinical trials in Congo's growing outbreak, marking a policy shift as researchers test potential treatments for the deadly Bundibugyo strain.
After COVID, The US Is Turning To The Same Organization To Fight Ebola In DR Congo

Credit: iStock

The United States is now providing doses of an experimental Ebola treatment developed by Mapp Biopharmaceutical for clinical trials in the Democratic Republic of Congo, where a growing outbreak of the Bundibugyo strain has infected more than 1,000 people and claimed over 250 lives. The decision marks a significant shift from the U.S. government's earlier stance, which limited access to the drug to Americans considered at high risk of exposure.

Health officials are racing to find effective ways to contain the outbreak, as there are currently no approved vaccines or treatments specifically designed for the Bundibugyo strain of Ebola. A small number of cases and deaths have also been reported in neighboring Uganda, raising concerns about the disease spreading further across the region.

The experimental therapy, known as MBP134, was developed by San Diego-based Mapp Biopharmaceutical. While the U.S. had previously kept its stockpile for potential use in exposed American citizens, it is now making doses available to support clinical research in Congo. This is the first time Washington has publicly committed stockpiled supplies of the treatment for a broader international trial.

According to the World Health Organization, researchers will test MBP134 both on its own and alongside the antiviral drug remdesivir, marketed as Veklury. Remdesivir became widely known during the COVID-19 pandemic and is being evaluated to see whether it can improve outcomes when combined with the antibody treatment.

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Ebola Situation In Western Africa

The confirmed cases in the Ebola outbreak in the Democratic Republic of Congo (DRC) have reached the highest total ever recorded during the first month of an outbreak in Africa, according to the World Health Organization (WHO).

As of June 22, confirmed Ebola cases in Congo had risen to 1,094 and deaths to 277, according to the DRC Ministry of Health. The WHO raised concerns about the rapid spread of the deadly virus and the challenges facing containment efforts.

“This is the largest number of confirmed cases in the first month of an Ebola disease outbreak in Africa,” said Dr Abdirahman Mahamud, Director, Health Emergency Alert and Response Operations at WHO, during a press briefing in Geneva.

"What is important is we need to scale up and this outbreak is moving faster than us," he told reporters after returning from Bunia last week.

Mahamud also noted signs of hope, highlighting a quick increase in the number of Ebola beds to over 500 in the past fortnight and signs that community resistance and violent resistance to Ebola responders was beginning to abate.

As of June 24, Uganda had recorded 20 confirmed Ebola cases, including two fatalities. The latest infection was identified on June 21, with no additional cases reported afterward. Of the confirmed infections, 15 were linked to travel from the Democratic Republic of the Congo (DRC), while five resulted from local transmission. Among the nine cases with available location data, eight were detected in Kampala and one in the neighboring Wakiso District.

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Could Chemotherapy Soon Be Optional? AstraZeneca and Gilead Drugs Show Promise for Breast Cancer Patients

Updated Jun 25, 2026 | 08:00 PM IST

SummaryClinical trials showed that both Datroway, developed by AstraZeneca in partnership with Daiichi Sankyo, and Trodelvy from Gilead Sciences reduced the risk of disease progression by about 40% compared with standard chemotherapy.
Could Chemotherapy Soon Be Optional? AstraZeneca and Gilead Drugs Show Promise for Breast Cancer Patients

Credit: AI generated image

Chemotherapy is often considered the most challenging aspect of cancer treatment due to its wide range of side effects. However, new advances in targeted therapies may soon reduce the need for conventional chemotherapy for some breast cancer patients.

Two drugs developed by pharmaceutical giants AstraZeneca and Gilead Sciences have shown encouraging results in treating triple-negative breast cancer (TNBC), one of the most aggressive and difficult-to-treat forms of the disease.

Triple-negative breast cancer lacks three key receptors commonly targeted by standard breast cancer therapies, making many conventional treatments ineffective.

In recent weeks, the US Food and Drug Administration (FDA) approved two targeted therapies—Datroway, developed by AstraZeneca in partnership with Daiichi Sankyo, and Trodelvy from Gilead Sciences—as first-line treatment options for certain patients with advanced triple-negative breast cancer.

Why These Drugs Are Better Than Chemo?

Also read: X-Men Star Tyler Mane Reveals ‘Super-Rare’ Male Breast Cancer Diagnosis

Both Datroway and Trodelvy belong to a class of medicines known as antibody-drug conjugates (ADCs). These therapies use antibodies to identify proteins present on most triple-negative breast cancer cells and deliver a potent dose of chemotherapy directly to the tumor.

The approach is designed to minimize damage to healthy tissues compared with traditional chemotherapy, which affects rapidly dividing cells throughout the body. Clinical trials showed that both drugs reduced the risk of disease progression by about 40% compared with standard chemotherapy, Washington Post reported.

“For seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option," said Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, in a statement.

The new drugs for the first time, will pave the way "for these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment.”

Efficacy of Trodelvy And Datroway

Gilead's approval is based on two clinical trials that evaluated how effectively Trodelvy delayed tumor growth. When used alone, Trodelvy reduced the risk of tumor progression or death by 38% compared with chemotherapy in patients who were not eligible for immunotherapy.

Among patients eligible for immunotherapy—approximately 30% of all triple-negative breast cancer cases—a combination of Trodelvy and Merck's Keytruda reduced the risk of tumor progression or death by 35%.

“For more than twenty years, patients with mTNBC have had limited choices in first-line treatment. Building on its impact in second-line mTNBC, Trodelvy now offers patients a powerful new backbone therapy option in the first-line setting,” said Dietmar Berger, Chief Medical Officer, Gilead Sciences, in a statement.

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In a separate clinical trial, AstraZeneca's Datroway reduced the risk of tumor progression or death by 43% compared with chemotherapy. The drug also extended median progression-free survival by five months.

“Datopotamab deruxtecan (brand name Datroway) is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. This approval will bring a much-needed treatment option for these patients,” said Tiffany A. Traina, Triple-Negative Breast Cancer Clinical Research Program, Memorial Sloan Kettering Cancer Centre, part of the study.

Burden Of Triple-negative Breast Cancer

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Triple-negative breast cancer (TNBC) represents about 10–15% of global breast cancer cases but accounts for a disproportionately high share of mortality. In 2025, more than 48,000 Americans were diagnosed with triple-negative breast cancer.

The disease is known for its aggressive nature. On average, triple-negative breast cancer recurs or spreads within about 2½ years, compared with around five years for other forms of breast cancer. Additionally, nearly half of patients never receive a second line of treatment.

Both AstraZeneca and Gilead are now investigating their therapies in earlier stages of breast cancer.

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