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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Jalen Hurts’ Blood Clots: How A Leg Clot Can Travel To The Lungs

Updated Oct 21, 2026 | 02:14 PM IST

SummaryEven fit people can develop blood clots due to injuries or prolonged immobility, including during long-haul flights. If a clot travels from the leg to the lungs, it can cause a potentially life-threatening pulmonary embolism (PE).
Jalen Hurts’ Blood Clots: How A Leg Clot Can Travel To The Lungs

Credit: Instagram

Philadelphia Eagles quarterback Jalen Hurts is expected to miss the remainder of the 2026 NFL season after being diagnosed with deep vein thrombosis (DVT) and blood clots in both lungs.

In a statement on October 19, the team said the 28-year-old was clinically stable with no significant functional limitations. However, he needs blood thinners and cannot participate in contact sports while taking them.

His diagnosis raises questions about how blood clots travel from the legs to the lungs, why they are dangerous and how to reduce the risk.

What Happened To Jalen Hurts?

Hurts was initially diagnosed with a superficial blood clot in his left calf after reporting discomfort following a cleat injury during the October 4 game against the Los Angeles Rams.

Although doctors initially cleared him to play, a follow-up ultrasound in Philadelphia and further testing identified DVT and blood clots in both lungs, known as bilateral pulmonary emboli.

The team said his treatment would involve anticoagulants, or blood thinners. He can resume football activities once he stops taking the medication.

Also read: Hours Of Sitting, Gaming And Binge-Watching OTT? Doctors Warn Of Blood Clot Risk In Young People

What Is Deep Vein Thrombosis?

Deep vein thrombosis occurs when a blood clot forms in a deep vein, usually in the leg. If part of the clot breaks away and travels to the lungs, it can cause a pulmonary embolism (PE), a potentially life-threatening condition.

Prolonged sitting, hospitalization, bed rest, injuries and certain genetic factors can increase the risk of developing blood clots.

How Can A Leg Clot Travel To The Lungs?

A clot can break away from a deep vein in the leg, travel to the right side of the heart and then enter the arteries supplying the lungs. There, it can block blood flow and strain the heart.

“You have a clot in your leg. The problem is it can travel up the veins and go to your heart, and from there, go to your lungs, and block the blood vessels in your lungs,” CBS News chief medical correspondent Dr. Jon LaPook, who is not treating Hurts, told CBS Mornings.

“That's very serious,” he added.

Why Are Athletes At Risk Of Blood Clots?

Read More: World Thrombosis Day: Can An Unexplained Blood Clot Be The First Sign Of Cancer? Experts Explain

Hurts is not the first high-profile athlete to experience blood clots. Tennis star Serena Williams has a history of clots, while NBA Hall of Famer Chris Bosh retired early following blood-clot-related complications.

Fitness does not eliminate the risk. Injuries and prolonged immobility, including during long-haul flights, can slow blood flow and contribute to clot formation.

DJ Corey, director of Northeastern University’s EMT program, said extended periods of sitting during air or road travel can increase the risk because leg muscles help maintain blood circulation.

The US Centers for Disease Control and Prevention (CDC) also warns that limited mobility during long-distance travel can increase the risk of venous thromboembolism (VTE), which includes DVT and pulmonary embolism.

How Can Travellers Reduce Their Risk?

To improve circulation during long journeys, the CDC recommends:

  • Moving the legs frequently while seated.
  • Walking periodically when it is safe to do so.
  • Avoiding prolonged immobility.
  • Consulting a doctor about preventive measures if you have additional risk factors.

Compression stockings may help some travellers at increased risk, depending on their medical needs.

What Are The Warning Signs Of Blood Clots?

DVT symptoms can include leg swelling, pain, tenderness, warmth and skin discoloration. Some people may have no obvious symptoms.

Pulmonary embolism warning signs include sudden breathlessness, chest pain, a rapid heartbeat, lightheadedness and coughing up blood.

Sudden breathing difficulties, chest pain or fainting require immediate medical attention, as a pulmonary embolism can be life-threatening.

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Mounjaro, Zepbound Ingredient Recalled In US Over Sterility Concerns

Updated Oct 21, 2026 | 11:00 AM IST

Summary​The FDA classified the recall of compounded tirzepatide as Class II, meaning the affected products could cause temporary or medically reversible adverse health consequences.
Mounjaro, Zepbound Ingredient Recalled In US Over Sterility Concerns

Credit: iStock

More than 20 vials of compounded tirzepatide, a GLP-1 medication containing the same active ingredient as Eli Lilly’s Mounjaro and Zepbound, have been recalled in the US over sterility concerns, according to the Food and Drug Administration (FDA).

The recall, issued by Apothecary Pharma, also includes a vial of NAD+ injection.

The FDA classified the recall as Class II, meaning the affected products could cause temporary or medically reversible adverse health consequences, while the likelihood of serious harm is considered low.

The recall follows a December 2025 FDA warning letter to Apothecary Pharma, which cited serious deficiencies in the North Carolina company’s sterile drug production practices.

The recalled injections are compounded versions of tirzepatide. Unlike FDA-approved, brand-name medications, compounded drugs are custom-prepared by pharmacies to meet specific patient needs.

Which Compounded GLP-1 Injections Were Recalled?

Also read: US FDA May Allow Pharmacies To Make Unapproved Peptide Injections: What Are the Safety Concerns?

The affected tirzepatide product is a prescription injection with a concentration of 18 mg/mL, supplied in a 4 mL multidose vial. Its National Drug Code (NDC) number is 85091-001-18.

The recalled lot numbers are AP-202622 through AP-202625 and AP-202627 through AP-202644. The products have beyond-use dates ranging from October 7 to November 26, 2026.

The recall also includes one vial of NAD+ injection.

What Should You Do If You Have a Recalled Vial?

The FDA and Apothecary Pharma have not issued a public statement clarifying what patients should do with the affected vials. Some customers have reported receiving requests through their prescribers to return or dispose of the products or contact the manufacturer directly.

NewLife Rx, a pharmaceutical fulfillment service that distributed some of the recalled vials, reportedly told certain customers that Apothecary had described the recall as a documentation issue.

According to a notice reviewed by USA TODAY, the recall was conducted at the retail level and did not extend to patients or require them to stop using or return their medications.

However, neither the FDA nor Apothecary Pharma has publicly clarified the reason for the recall or the safety of the affected products.

Although a Class II classification indicates a relatively low likelihood of serious harm, it does not mean a product is entirely risk-free.

If you have an affected lot, consult your prescriber or healthcare provider before using it again and follow their instructions.

Read More: Retatrutide Driving Peptide-Linked Emergency Hospital Admissions In Australia: What Are The Risks?

What Are the Risks of Compounded GLP-1 Drugs?

A compounded drug is a medication prepared by a compounding pharmacy to meet an individual patient's specific medical needs. This may include removing an allergen, adjusting a dosage, or preparing a formulation that is not commercially available.

While these medications can serve specific medical needs, they are not FDA-approved in the same way as branded drugs. The FDA does not review compounded formulations for safety, effectiveness, and quality before they are marketed.

Demand for GLP-1 medications for weight loss skyrocketed worldwide between 2022 and 2025, leading to shortages of semaglutide and tirzepatide.

During these shortages, compounding pharmacies were legally allowed under specific circumstances to prepare several versions of these medications.

Many patients turned to compounded GLP-1s because they were often affordable, available, and easier to buy online.

Potential risks of compounded GLP-1 drugs include:

  • Inaccurate Dosing
  • Sterility Concerns
  • Different Ingredients
  • Limited Safety Data
  • Counterfeit or Unregulated Products

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US FDA Approves First-Of-Its-Kind Hepatitis B Drug That Helped 19% Patients Stay Off Treatment For Six Months

Updated Oct 21, 2026 | 08:23 AM IST

SummaryThe US FDA recently approved Hibsago (bepirovirsen), a new drug for chronic hepatitis B that could help control viral activity after stopping all antiviral treatment.
US FDA Approves First-Of-Its-Kind Hepatitis B Drug That Helped 19% Patients Stay Off Treatment For Six Months

Credit: AI

The US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen), a first-of-its kind treatment for certain adults with chronic hepatitis B. The drug controlled virus activity in some patients after stopping all treatment.

Announced on October 20, 2026, the approval makes Hibsago the first FDA-approved antisense oligonucleotide for chronic hepatitis B.

It is approved for certain adults without cirrhosis who have already been taking antiviral medication for at least six months, have suppressed levels of hepatitis B virus (HBV) and meet specific criteria for hepatitis B surface antigen (HBsAg).

In clinical trials, 19% of patients receiving Hibsago maintained viral control 24 weeks after stopping all hepatitis B treatment. No amount of HBsAg was detected in their blood. The treatment is meant to offer an alternative for some patients who otherwise need long-term antiviral medication.

“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Wendy Carter, DO, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

“Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.”

How Does Hibsago Work?

Hibsago targets the genetic aspects the hepatitis B virus targets. By reducing viral RNA and hepatitis B surface antigen, the drug helps the immune system control the infection even after after treatment ends.

The drug is administered as an injection under the skin for up to 24 weeks, alongside a patient's existing hepatitis B medication. Patients continue their treatment for at least 24 weeks after the final Hibsago injection. They can then stop all treatment if they meet specified clinical and laboratory criteria.

The FDA also authorised a diagnostic test to help identify eligible patients and monitor them during treatment.

Also read: G155E H1N1 Mutation In US Raises Concerns: Can This Year’s Flu Shot Still Protect You?

What Did The Clinical Trials Find?

The approval was supported by two Phase 3 trials, B-Well 1 and B-Well 2, which compared Hibsago with a placebo in adults receiving established antiviral treatment.

Across the trials, 24% of patients receiving Hibsago met the criteria to stop their existing antiviral medication, compared to none in the placebo groups.

At 24 weeks after stopping all treatment, 19% of patients receiving Hibsago maintained viral control. Hepatitis B surface antigen was also no longer detectable in their blood.

The outcome means the virus remains controlled without ongoing treatment according to specified laboratory criteria.

Also read: H. pylori, HPV Among Five Infections Behind 1 In 8 Cancers Worldwide: Lancet

What Are The Risks?

Hibsago carries a warning for serious liver reactions and thrombocytopenia, or low platelet counts, which can increase the risk of life-threatening bleeding.

Other warnings include poor kidney function and inflammatory reactions like vasculitis. Patients require regular blood tests and medical monitoring before and during treatment.

The FDA granted Hibsago Fast Track and Breakthrough Therapy designations, along with Priority Review. The drug was approved for GSK plc.

The treatment is not suitable for everyone with chronic hepatitis B. Eligibility depends on liver health, existing treatment, viral suppression and laboratory results.

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