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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AI-Created Virus Injected Into A Human For The First Time To Fight Antibiotic Resistance

Updated Oct 31, 2026 | 02:00 AM IST

SummaryAI-designed bacteriophages generated by Radical Numerics' Omnii-1 model have been administered to a human patient for the first time under compassionate use to target an antibiotic-resistant bacterial infection. The trial had reportedly been authorized by the Food and Drug Administration.
AI-Created Virus Injected Into A Human For The First Time To Fight Antibiotic-Resistant Infection

Credit: Radical Numerics

In a world first, scientists have administered AI-designed viruses to a human patient to treat a serious antibiotic-resistant bacterial infection. The experimental treatment marks a milestone in the development of personalized therapies that use artificial intelligence (AI) to design viruses capable of targeting drug-resistant bacteria.

California-based AI startup Radical Numerics announced the development in a blog post, saying a patient with a serious bacterial infection received an experimental treatment containing viruses generated by its AI model, Omnii-1.

How AI Helped Design the Viruses

Also read: AI Creates 16 Viruses To Kill Drug-Resistant E. coli, Raises Biosafety Concerns

The treatment uses bacteriophages, or phages, which are viruses that infect and kill bacteria. Phage therapy is being explored as an alternative when antibiotics fail, particularly in drug-resistant infections.

However, identifying phages that can effectively target the specific bacteria causing an individual patient's infection remains a major challenge.

Antibiotic resistance is a growing global health threat. A 2024 study published in The Lancet projected that bacterial antimicrobial resistance could directly cause 39.1 million deaths globally between 2025 and 2050.

Radical Numerics said it trained Omnii-1, its multimodal genome language model, to address the challenge of identifying and designing effective phages.

"We trained Omnii-1, our multimodal genome language model, to help bridge this gap. We demonstrate that it can generate viable phages, prioritize variants, and predict phage-host interactions," the company said.

"In the world's first clinical use of AI-generated phages, Omnii-1 designs were administered to a human patient under compassionate use," it added.

How Did the AI-Designed Phage Treatment Work?

Read More: Anthropic Says Claude Blocked Bird Flu, Chikungunya Research: How AI Could Enable Biological Misuse

According to the company, researchers tested the AI-designed viruses against bacteria obtained from the patient before administering the treatment. The resulting phage cocktail eliminated the patient's antibiotic-resistant bacterial sample in laboratory testing.

The treatment was administered under an authorized, physician-led compassionate-use pathway. Compassionate use allows patients with serious conditions to access investigational treatments outside clinical trials when satisfactory alternatives are unavailable, subject to regulatory authorization and appropriate oversight.

The report has not been peer-reviewed or published in a scientific journal. Company officials said the trial had been authorized by the Food and Drug Administration, the New York Times reported.

The company has not disclosed the patient's diagnosis, clinical course or treatment outcome, citing privacy concerns. It is therefore unclear whether the treatment successfully cleared the infection.

Eric Nguyen, chief executive officer of Radical Numerics, said the company was prioritizing patient confidentiality and intended to publish its findings through peer-reviewed research.

"We intend to publish our scientific findings through peer-reviewed research, with any future disclosure of clinical details subject to appropriate consent," he added.

The company said making phage therapy accessible to more patients would require reliable workflows for designing effective phages against individual bacterial infections.

Previous Research Used AI to Design Bacteria-Killing Viruses

The development comes amid growing interest in using AI to accelerate medical research, including the design of new biological therapies.

In August 2026, researchers at Stanford University and the Arc Institute announced that they had used AI to design previously unseen bacteriophages capable of killing E. coli bacteria in laboratory experiments.

Of nearly 300 AI-designed phages synthesized and tested, 16 produced functional viruses. However, these experiments were conducted in bacteria and did not involve human patients.

The Radical Numerics development goes a step further by reporting the clinical administration of AI-designed phages to a human patient.

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Nearly 1 in 7 American Children Had an ADHD Diagnosis in 2025: US CDC

Updated Oct 31, 2026 | 12:00 AM IST

Summary​The percentage of children who had ever been diagnosed with ADHD increased by 3.9 percentage points over the seven years, representing a relative rise of approximately 39%. More boys received the diagnoses than girls.
Nearly 1 in 7 US Children Had an ADHD Diagnosis in 2025: CDC

Credit: iStock

The share of US children aged 5–17 who had ever received an attention-deficit/hyperactivity disorder (ADHD) diagnosis increased from 9.9% in 2019 to 13.8% in 2025, according to new CDC data.

Nearly 1 in 7 children and adolescents aged 5–17 in the US have received an ADHD diagnosis, according to a QuickStats report published in the CDC's latest Morbidity and Mortality Weekly Report (MMWR).

The National Center for Health Statistics (NCHS) found that the percentage of children who had ever been diagnosed with ADHD increased by 3.9 percentage points over the seven years, representing a relative rise of approximately 39%.

More boys received the diagnoses than girls throughout the period, although the trends fluctuated from year to year.

ADHD Diagnoses Among US Children: Trends From 2019 to 2025

Also read: ADHD Linked To 71% Higher Risk Of Death; Suicide And Injuries Among Top Concerns

According to the CDC data, the percentage of US children and adolescents aged 5–17 who had ever received an ADHD diagnosis rose from 9.9% in 2019 to 11.6% in 2020. It dipped to 10.8% in 2021 before increasing to 11.5% in 2022.

The figure climbed to 13.4% in 2023, 13.6% in 2024 and 13.8% in 2025.

Among boys, the percentage increased from 13.2% in 2019 to 17.5% in 2025, reaching a high of 17.6% in 2024.

Among girls, it rose from 6.5% in 2019 to 9.9% in 2025, although it dipped from 9.9% in 2023 to 9.3% in 2024.

The estimates are based on household interviews with a sample of the civilian, noninstitutionalised US population. The survey considered children to have an ADHD diagnosis if a parent or respondent answered yes to whether a doctor or health professional had ever told them the child had ADHD or attention-deficit disorder (ADD).

Nearly 1 in 7 American Children Had an ADHD Diagnosis in 2025: US CDC

What Is ADHD?

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental condition that affects attention, executive function, impulse control and activity levels. It typically begins in childhood, with symptoms appearing before age 12, and can persist into adulthood.

Read More: Attention Deficit May Be The Wrong Way To Understand ADHD, Says US Psychiatrist

What Are the Symptoms of ADHD?

According to the National Institute of Mental Health (NIMH), ADHD symptoms fall into two primary categories:

  • Inattention: Difficulty sustaining focus, missing details, making careless mistakes, forgetfulness in daily routines and struggling to stay organised.
  • Hyperactivity and impulsivity: Fidgeting, excessive talking, restlessness, interrupting others and acting without thinking. In adults, hyperactivity may also manifest as internal restlessness.

AAP Guidance on ADHD Evaluation and Treatment in Children

The American Academy of Pediatrics (AAP) 2019 clinical practice guideline recommends that primary care clinicians initiate an ADHD evaluation for children and adolescents aged 4–18 who present with academic or behavioural problems and symptoms of inattention, hyperactivity or impulsivity.

The guideline recommends assessing children using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, based on information from parents, teachers and other school personnel.

It also calls for screening for coexisting emotional, behavioural, developmental and physical conditions.

For preschool-aged children, parent training in behaviour management is recommended as a first-line approach.

For school-aged children and adolescents, the AAP recommends FDA-approved medication alongside behavioural and school-based interventions. It also emphasises managing ADHD as a chronic condition, with ongoing monitoring and follow-up.

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World's First Patient Receives Pioneering Stem Cell Treatment For Parkinson's In Japan

Updated Oct 30, 2026 | 09:11 PM IST

SummaryThe treatment uses iPSCs obtained from healthy donors, which are developed into precursors of dopamine-producing neurons and transplanted into the brain to replace cells lost due to Parkinson's disease.
World's First Patient Receives Pioneering Stem Cell Treatment For Parkinson's In Japan

Credit: iStock

A patient has received a pioneering stem cell treatment for Parkinson's disease in Japan, marking a world first following the therapy's conditional approval in the country.

Developed by Japanese drugmaker Sumitomo Pharma in collaboration with Dr Jun Takahashi at Kyoto University, the therapy, Amchepry (also known as raguneprocel), is the world's first induced pluripotent stem cell (iPSC)-based treatment for Parkinson's disease. It received conditional approval in March 2026 following successful clinical trial results.

The first transplant was performed at Kyoto University Hospital in October, the company said on Friday in an earnings press release, without providing further details, AFP reported.

How Does the Parkinson's Stem Cell Treatment Work?

Also read: Parkinson’s at 40: Why Younger Adults Are Being Diagnosed Earlier Than Before

The treatment uses iPSCs obtained from healthy donors, which are developed into precursors of dopamine-producing neurons and transplanted into the brain to replace cells lost due to Parkinson's disease.

iPSCs are created by reprogramming mature, specialised cells to return to an earlier state, allowing them to develop into different cell types.

Stem cell therapy, also known as regenerative medicine, uses stem cells or their derivatives to repair or replace damaged tissues.

What Did the Clinical Trial Find?

During the clinical trial, seven patients aged between 50 and 69 received implants of either five million or 10 million cells on both sides of the brain.

The patients were monitored for two years. Researchers found no major adverse effects, while four participants showed improvements in their symptoms, AFP reported.

Sumitomo Pharma said it plans to perform transplants in 20 to 30 patients by March 2029. The company is also conducting a clinical trial of the treatment in the United States.

The therapy will receive full approval in Japan if its safety and effectiveness are confirmed over the next seven years, according to local media reports.

Read More: Parkinson’s Disease: Women Have More Motor Complications, Depression

Japan Also Approves Stem Cell Therapy for Heart Failure

The announcement comes a month after a hospital in Osaka performed the world's first surgery using sheets of heart muscle cells derived from iPSCs.

The sheets are designed to promote new blood vessel formation and help restore heart function. The treatment also received conditional approval in Japan in March.

Conditional approval allows these therapies to be used clinically while additional data on their safety and effectiveness are collected.

What Is Parkinson's Disease?

Parkinson's disease is a progressive neurodegenerative disorder caused by the loss of dopamine-producing brain cells. It primarily affects people over the age of 60 and is estimated to affect more than 10 million people worldwide, according to the Parkinson's Foundation.

Dopamine plays an important role in controlling movement. Its loss can cause symptoms such as:

  • Tremors, often beginning in one hand, foot or the jaw.
  • Muscle stiffness and slowed movement.
  • Difficulty maintaining balance, increasing the risk of falls.
  • Changes in speech, including softer or slurred speech.
  • Difficulty swallowing.

The disease can also cause cognitive decline, depression and anxiety. Currently available treatments help manage symptoms but do not stop or reverse disease progression, according to the Parkinson's Foundation.

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