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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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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Baby Formula Nutrition: US FDA Proposes Changes to Vitamins A, D, Iodine and Manganese – What Parents Must Know

Updated Oct 30, 2026 | 06:00 PM IST

SummaryThe FDA says formulas currently sold in the US remain safe for babies. The proposed changes are not prompted by safety concerns but aim to align standards with current scientific evidence. The agency noted that parents do not need to change the formula they currently use.
Baby Formula Nutrition: US FDA Proposes Changes to Vitamins A, D, Iodine and Manganese – What Parents Must Know

Credit: iStock

For the first time in nearly three decades, the US Food and Drug Administration (FDA) is proposing changes to nutrient requirements for infant formula. The proposed changes cover vitamins A and D, iodine and manganese under the Trump administration's Operation Stork Speed initiative, announced in March 2025.

The FDA’s first phase of a three-phase review covers eight of the 30 nutrients required in infant formula. It proposes revising requirements for four nutrients and reaffirming existing limits for the other four. It is also seeking public input on nutrients commonly added by manufacturers but not currently required. The agency is accepting comments for 120 days.

“Parents deserve confidence in every bottle they feed their baby,” US Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement.

What Are The Proposed Changes?

Also read: Major FDA Study Confirms Baby Formula In US Safe, Testing to Continue

The FDA's first phase covers eight nutrients. It proposes changes to four and retaining existing limits for the other four.

1. Iodine

  • Minimum: Increased from 5 to 15 µg/100 kcal.
  • Maximum: Reduced from 75 to 50 µg/100 kcal.

2. Manganese

  • Minimum: Reduced from 5 to 1 µg/100 kcal.
  • Maximum: A new limit of 50 µg/100 kcal.

3. Vitamin A

  • Measurement unit changed from IU to micrograms of retinol activity equivalents (µg RAE).
  • Minimum: Reduced from 250 IU (75 µg RAE) to 70 µg RAE/100 kcal.
  • Maximum: Reduced from 750 IU (225 µg RAE) to 120 µg RAE/100 kcal.
  • Only preformed vitamin A, not beta-carotene, will count towards the limits.

4. Vitamin D

  • Measurement unit changed from IU to micrograms (µg).
  • Minimum: Increased from 40 IU (1 µg) to 2 µg (80 IU)/100 kcal.
  • Maximum: Increased from 100 IU (2.5 µg) to 3 µg (120 IU)/100 kcal.

The FDA also proposes updating formula labelling requirements to reflect the changes.

Which Nutrient Limits Will Remain Unchanged?

Read More: New International Food Pyramid Highlights Plant Foods, Counters Trump’s Meat-Heavy Diet Advice

The FDA proposes retaining existing levels for:

  • Chloride: 55–150 mg/100 kcal.
  • Potassium: 80–200 mg/100 kcal.
  • Selenium: 2–7 µg/100 kcal.
  • Sodium: 20–60 mg/100 kcal.

What Do Parents Need To Know?

The FDA says formulas currently sold in the US remain safe for babies. The proposed changes are not prompted by safety concerns but aim to align standards with current scientific evidence.

Parents do not need to change the formula they currently use.

When Will The Changes Take Effect?

The FDA is reviewing all 30 nutrients in three phases. The first covers eight, with the remaining 22 to follow.

The final rule will take effect 60 days after publication in the Federal Register. Manufacturers will have three years from that date to reformulate and relabel their products.

This means the proposed changes will not appear on formula packaging immediately.

Dr Steven Abrams, a paediatrician and professor at the University of Texas' Dell Medical School, called the update overdue. He described the first phase as “really well done” and “very well thought-out”, CNN reported.

However, he said the phased approach means manufacturers could take several years to implement the changes.

“These changes that they're recommending today are not going to be something that'll show up on the can of formula potentially for several years,” Abrams said.

He identified the proposed vitamin D increase as the most consequential change in this phase.

Meanwhile, the FDA is also seeking input on making commonly added nutrients such as DHA, ARA and L-carnitine mandatory. These are not currently required in infant formula.

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Ebola 2026 Outbreak: Death Toll Nears 5,000; Kenya, Nigeria Cases Linked to Congo

Updated Oct 30, 2026 | 02:35 PM IST

SummaryGenetic analysis has linked Ebola cases in Kenya and Nigeria to viruses circulating in eastern DRC, with investigators probing possible transmission routes through Uganda. The 2026 outbreak has so far killed nearly 5,000 people, including more than 1,000 children, with numbers expected to surge.
Ebola 2026 Outbreak: Death Toll Nears 5,000; Kenya, Nigeria Cases Linked to Congo

Credit: iStock

The Ebola outbreak in the Democratic Republic of Congo (DRC), officially declared a Public Health Emergency in May 2026, has surpassed 10,000 cases and is approaching 5,000 deaths, making it the fastest-growing Ebola outbreak in history.

Driven by the Bundibugyo Ebola virus, the outbreak has spread beyond the DRC to Uganda, Kenya and Nigeria, raising concerns about cross-border transmission. There is currently no licensed vaccine against this strain, although candidates are in development.

More than 1,000 children have died, accounting for over one-quarter of recorded fatalities, according to Save the Children.

“It's extraordinarily serious. Over 1,000 children have died of Ebola,” Greg Ramm, Save the Children's Country Director in the DRC, told the media.

“The world needs to start paying attention. We will break 15,000 deaths by the new year. And just because Ebola isn’t going to become a pandemic doesn’t mean it is not a global health security threat as well as a humanitarian disaster,” Dr Angela Rasmussen, a virologist, warned in a post on X.

Africa CDC Warns of Wider Global Risk

Africa CDC Director-General Dr Jean Kaseya has warned that the outbreak's unprecedented geographical spread could put countries beyond Africa, including the UK, at risk.

“The geographic extension of this outbreak is unprecedented,” he said, noting that three African regions had been affected. Drawing parallels with COVID-19, he warned: “We don’t want to see the UK and other countries become the hotspot,” The Guardian reported.

In response, the UK Health Security Agency's (UKHSA) Dr Sam Collins stressed that the risk to the UK remains low and that the country “is well prepared to respond safely and effectively to the risk of imported cases arising here”.

Genetic Analysis Links Kenya, Nigeria Cases to Congo

Scientists have linked Ebola viruses detected in Kenya and Nigeria to those circulating in Beni, eastern DRC, raising questions about a possible shared transmission chain or an unidentified source, Bloomberg reported.

“Genomic sequencing shows that the Ebola virus from Nigeria’s recently reported only imported case is highly similar to that from Kenya’s first imported case, differing by only one mutation,” Muhammad Ali Pate, Nigeria's Coordinating Minister of Health and Social Welfare, said in a post on X.

How Was The Genetic Analysis Conducted?

Scientists from four countries, led by Congolese virologist Jean-Jacques Muyembe, analysed 1,126 viral genomes after an Ebola case was detected in Abuja, Nigeria.

The Beni samples share a distinctive genetic signature, including a mutation absent from other sequenced viruses from Congo.

The viruses also lack genetic markers associated with Uganda's documented Ebola transmission chains from May and June, suggesting they did not descend from those previously identified outbreaks.

Researchers have yet to establish where the patients contracted the virus or whether they were infected through the same transmission chain. Genetic sequencing alone cannot prove direct transmission.

Travel Histories Point To Possible Congo Uganda Connection

Investigators are examining the patients' movements through Uganda during their potential exposure periods.

The Nigerian patient was in Uganda from September 15 to October 3 and developed symptoms three days after returning to Abuja. The Kenyan patient travelled from Congo through Uganda between October 1 and 3 before flying to Nairobi from Entebbe.

Both patients reportedly travelled on flights on October 3. Authorities are checking their travel records for possible overlap and tracing potentially exposed passengers.

Nigeria, Kenya Step Up Ebola Response

Nigeria has traced 62 contacts of the infected woman, NCDC Director-General Jide Idris said. Of these, 50 are in isolation, five are being monitored at home and seven remain unlocated.

Uganda recorded 20 confirmed cases and two deaths before declaring the outbreak over in June.

Kenya has reported nine cases and two deaths. Seven patients, including three family members and four healthcare workers, are receiving treatment and responding well. Authorities have traced all 135 contacts linked to the first case, according to official data.

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