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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US FDA Recalls Injectables Over Fiberglass, Steel Particles: See Affected Drugs

Updated Aug 28, 2026 | 06:01 PM IST

SummaryBaxter voluntarily recalled two injections used to provide nutrition, water, and electrolytes to patients. A third injectable, anticoagulant — a substance used to slow blood clotting — was also recalled, but the affected product was distributed to only one customer.
US FDA Recalls Injectables Over Fiberglass, Steel Particles: See Affected Drugs

Credit: iStock

The US Food and Drug Administration (FDA) has announced recalls of multiple injectable drugs from Baxter International over potential contamination with fiberglass and stainless-steel particles.

Baxter voluntarily recalled:

  • two injections used to provide nutrition, water, and electrolytes to patients.
  • an injectable anticoagulant — a substance used to slow blood clotting — was also recalled, but the affected product was distributed to only one customer.

In a notice, the FDA said the medications could be contaminated with fiberglass or stainless-steel particles. Injecting contaminated products intravenously may lead to serious adverse health consequences.

“Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death,” the FDA said.

“Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic

reactions,” it added. Baxter said it has not received any reports of adverse events related to the issue.

Which Medications Were Recalled?

The recalled Baxter medications include:

  • 70% Dextrose Injection, USP, 2000 mL, in a Viaflex plastic container.
  • 0.9% Sodium Chloride Injection, USP, 500 mL, in a Viaflex plastic container.
  • Anticoagulant Sodium Citrate Solution USP, 250 mL, in a Viaflex plastic container. The FDA noted that this product was distributed to only one customer.

Nutrition Injection Recalled

The 70% Dextrose Injection is a liquid solution mixed with other fluids to provide calories and nutrition through a person's veins when they cannot get necessary nutrients by mouth or through a feeding tube, USA Today reported.

The impacted products were sold between July 25 and July 28 to healthcare providers and distributors in several states, including Alabama, Georgia and Tennessee. No adverse reactions have been reported.

Water And Electrolyte Injection Recalled

The 0.9% Sodium Chloride Injection is commonly used as a source of water and electrolytes. It is administered through the veins when a person cannot get adequate amounts through eating, drinking or other medical treatments.

The injection may also be used during medical procedures, including blood transfusions and hemodialysis, a procedure that helps filter waste from the blood when the kidneys cannot do so adequately.

The impacted product was distributed between July 31 and August 3 to healthcare providers and distributors in several states, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas and Virginia. No adverse reactions have been reported.

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H1N1 In Delhi: 166 Fresh Cases In 24 Hours, Tally Rises To 2,612

Updated Aug 28, 2026 | 11:57 AM IST

SummaryMost patients are presenting with flu-like symptoms, including cold, cough, body aches and upper respiratory tract infections. However, some doctors are also seeing atypical symptoms such as diarrhea also and myalgias, which are getting very, very frequent.
H1N1 In Delhi: 166 Fresh Cases In 24 Hours, Tally Rises To 2,612

Credit: iStock

India’s national capital is reporting a significant surge in influenza H1N1 cases. In the last 24 hours, Delhi reported 166 fresh H1N1 cases, up from 138 cases recorded the previous day, taking the cumulative tally to 2,612, officials said.

The total number of H1N1 cases in Delhi stood at 2,612, while cumulative Influenza-A cases were around 3,300, according to an official statement.

Delhi Reviews Hospital Preparedness

Health Minister Pankaj Kumar Singh inspected Indira Gandhi Hospital in Dwarka amid the rising number of H1N1 cases in the national capital and reviewed the hospital's and the Health Department's preparedness.

The Minister said he has been closely monitoring preparedness across hospitals.

Beyond Delhi, areas including Mumbai and Bengaluru have also reported a significant spike in H1N1 cases.

DG ICMR Dr. Rajiv Bahl said H1N1 in India is showing expected seasonal changes, with no unusual genetic shift detected.

“No cause for panic: seasonal influenza remains self-limiting; no new or unusual virus strain detected,” he added.

Doctors Flag Atypical H1N1 Symptoms

Influenza A (H1N1) is a seasonal respiratory infection that is mostly self-limiting in healthy adults. If symptoms persist beyond 5–6 days, or occur in young children, elderly persons or those with underlying medical conditions, consult a doctor or visit your nearest government health facility, the Health Ministry advised.

Dr. Atul Kakkar, Senior Consultant and Head of Department, Internal Medicine, Sir Ganga Ram Hospital, told HealthandMe that H1N1 cases are significantly higher than last year, possibly due in part to seasonal changes.

Most patients are presenting with flu-like symptoms, including cold, cough, body aches and upper respiratory tract infections.

However, doctors are also seeing atypical symptoms.

“We are seeing patients having diarrhea also and myalgias, which are getting very, very frequent.”

Patients at extreme ages are more prone to complications and may require oxygen, high-flow oxygen, NIV or BiPAP, he said. Those at higher risk include people who are unvaccinated against flu, patients undergoing chemotherapy, and those with COPD, bronchial asthma, cancer or those on immunosuppressive treatment.

H1N1 Can Affect The Heart

As per experts, H1N1 infection may also be associated with cardiovascular complications, including:

  • Heart inflammation
  • Abnormal heartbeats
  • Worsening heart failure
Dr. Saurabh Gupta, Associate Director, Internal Medicine, Yashoda Medicity, said H1N1 may cause fluctuations in heart rhythm or inflammation involving the heart.

“Those with pre-existing heart conditions should be more vigilant whilst they’re recuperating. As the infection puts more work on the body, you can find that previous heart problems are more noticeable,” he added.

H1N1 Can Affect The Eyes

While H1N1 primarily causes fever and respiratory symptoms, some people also have some eye discomfort and sudden vision changes.

Dr. Maitri Jindal Chowdhary, Consultant, Ophthalmology: Yashoda Medicity told HealthandMe that eye symptoms during H1N1 may manifest as a bit of redness, watery eyes, some irritation or dryness, which should resolve as the H1N1 is overcome. But a change in vision definitely warrant an eye professional’s attention.

The expert said that vision changes such as blurry or double vision, acute vision loss, seeing flashes of light or floaters or a drop in your vision should be brought to the attention of an eye doctor. Don’t automatically attribute such vision changes to your “flu”.

"Some eye concerns are of course not as serious. There might be some watering of eyes, slight discomfort that resolve as you feel better. However if symptoms such as sudden blurry vision persists, if eye irritation persists or worsens – you need to get yourself checked out.

Likewise if you feel pain in the eye, there’s an alarming redness, a lot of light sensitivity, swelling or an discharge - go get those eyes checked out," Dr. Maitri told HealthandMe.

Be very careful if you wear contact lenses. Do not wear them if your eyes become red, painful or vision blurring as this could worsen the issue. Remove your contacts immediately and seek attention.

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US FDA Approves Updated COVID Vaccines For 2026-27 Season: All You Should Know

Updated Aug 28, 2026 | 09:51 AM IST

SummaryFour COVID vaccines have been approved for use in the US after an advisory panel recommended that the shots target the dominant XFG variant.
US FDA Approves Updated COVID Vaccines For 2026-27 Season: All You Should Know

Credit: iStock

The US Food and Drug Administration (FDA) has approved updated COVID vaccines from Moderna, Pfizer-BioNTech and Novavax-Sanofi for the 2026-27 season, the companies said.

Four COVID vaccines have been approved for use in the US after an advisory panel recommended that the shots target the dominant XFG variant.

What Are The New COVID Vaccines?

Moderna: mNEXSPIKE and Spikevax

  • Spikevax: Approved for people aged 6 months through 64 who have an underlying condition, and anyone aged 65 or older.
  • mNEXSPIKE: Approved for people aged 12 through 64 who have an underlying condition, and anyone aged 65 or older.
The mRNA-based vaccines target the XFG subvariant of the JN.1 coronavirus strain.

Pfizer-BioNTech: Comirnaty

It is approved for:

  • All adults aged 65 and older.
  • People aged 5 through 64 who have a condition that raises their risk of severe illness.
The vaccine targets the LP.8.1 strain of the coronavirus.

Novavax-Sanofi: Nuvaxovid

  • Nuvaxovid is the only protein-based COVID vaccine available in the US. It is approved for everyone aged 65 and older and for those aged 12 through 64 who have underlying conditions.

The vaccine targets the JN.1 strain.

When Will The Updated Shots Be Available?

All manufacturers had previously said they could make the updated shots in time for the 2026-27 immunization season, although Novavax could take longer to manufacture its vaccine.

The Donald Trump administration had shelved the universal COVID vaccine recommendation. It now recommends that everyone aged 6 months and older consult a healthcare provider before getting the shot.

In May, eight of the committee's nine experts voted in favor of targeting the XFG variant for the 2026-27 campaign.

For the 2025-26 season, the FDA had recommended that COVID shots target LP.8.1, a subvariant of the JN.1 strain. The CDC has yet to make an official recommendation for this year's vaccines.

Experts say the vaccines should begin reaching pharmacies and doctors' offices in September, CNN reported.

What Is The Current COVID Situation In The US?

The CDC's latest respiratory illness data, updated August 21, shows that national and regional COVID-19 activity is increasing, although overall acute respiratory illness causing people to seek healthcare remains very low.

Doctors have been reporting an increase in patients testing positive through the summer. But some physicians are noticing a change in how the illness is presenting.

Reports have emerged stating that COVID is resurfacing with new symptoms including nausea, vomiting and diarrhoea.

COVID-19-related visits to the emergency room are also increasing.

Recent reports from doctors in Georgia describe patients arriving with gastrointestinal symptoms alongside, or sometimes instead of, the more familiar respiratory symptoms.

Although these symptoms may seem unusual compared with the classic COVID presentation, nausea, vomiting and diarrhoea are not new symptoms of COVID-19.

The CDC has included nausea, vomiting and diarrhoea among the possible symptoms of COVID-19 for years.

Dr James Black, medical director of emergency services at Phoebe Putney Memorial Hospital in Albany, Georgia, said doctors are still seeing fever, cough and upper-respiratory symptoms, but added, “A lot of people are coming in with gastrointestinal symptoms - nausea, vomiting, diarrhea, sometimes to the point of mild dehydration.”

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