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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FDA Reports Seven Deaths, 736 Serious Injuries Tied To Faulty Glucose Monitoring Devices

Updated Dec 5, 2025 | 12:00 AM IST

Summary Malfunctioning FreeStyle Libre 3 and Libre 3 Plus glucose sensors have been tied to seven possible deaths and hundreds of serious injuries, according to new FDA and Abbott alerts. Learn which devices are affected, the risks involved, and what users should do if their sensor is part of the correction.
glucose monitoring device

CREDITS: CANVA

Malfunctioning glucose sensors made by Abbott Diabetes Care have been tied to more than seven hundred serious medical events and seven possible deaths, according to updates from both Abbott and the Food and Drug Administration (FDA). The company issued a public notice on November 24 and sent letters to those who may be affected, explaining that it had begun a “medical device correction” for select FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.

On December 2, the FDA released an early safety communication, which is the type of alert shared when a product is corrected or removed because of a significant risk before the agency can determine whether an official recall is necessary.

FDA: Seven Deaths Possibly Linked To Malfunctioning Glucose Monitors

Some FreeStyle Libre 3 sensors may show falsely low blood sugar levels, which can lead people with diabetes to make treatment choices that are not appropriate for their actual condition. When someone’s glucose appears low, they might delay their insulin dose or skip it altogether, or they may eat more carbohydrates in an effort to raise their levels, as noted by USA Today.

When treatment decisions are based on incorrect readings, blood sugar can quickly become unstable. Poor glucose control can result in dangerous medical complications, including injury or even death. Problems linked to mismanaged diabetes can include diabetic ketoacidosis, heart issues, stroke, kidney damage, nerve and eye problems, and a higher chance of infection.

USA Today reports that the issue affects nearly three million Libre 3 and Libre 3 Plus sensors sold in the United States, and Abbott estimates that roughly half of them have already been used or have expired. Worldwide, the company has received 736 reports of severe adverse events (57 in the U.S.) and seven reports of deaths (none in the U.S.) that may be associated with this problem.

Which Abbott Diabetes Care Products Are Impacted?

Only specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus Continuous Glucose Monitoring Systems are affected. The FreeStyle Libre 3 handheld reader and mobile app are working normally.

No other Libre devices (FreeStyle Libre 14-day, FreeStyle Libre 2, FreeStyle Libre 2 Plus, or the FreeStyle Libre Pro sensors) or Abbott biowearable products are involved.

FreeStyle Libre 3 Sensor

  • Model Numbers: 72081-01, 72080-01
  • Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002

FreeStyle Libre 3 Plus Sensor

  • Model Numbers: 78768-01, 78769-01
  • Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014

The serial number for a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor is available in the app or reader, and it is also printed on the label at the bottom of the sensor applicator or on the carton. Consumers who are wearing a sensor that has been confirmed as part of the affected group should stop using it at once and safely discard it.

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Hepatitis B: CDC Panel To Review New Vaccine Guidance, Here’s What To Expect

Updated Dec 4, 2025 | 09:34 PM IST

SummaryA CDC vaccine advisory committee packed with new Kennedy-appointed members is set to revisit hepatitis B guidance, childhood vaccine timing, adjuvants, and key safety debates. Here is what you can expect as the two-day ACIP meeting unfolds.
hepatitis B cdc

Credits: Canva

The Centers for Disease Control and Prevention’s vaccine advisory committee will meet on Thursday and Friday to review the childhood vaccination schedule, look at adjuvants and possible contaminants, and revisit hepatitis B immunisation guidance.

This will be the third gathering this year of the Advisory Committee on Immunization Practices (ACIP) after Health and Human Services Secretary Robert F. Kennedy Jr. dismissed all 17 former members and brought in his own choices, many of whom have openly questioned long-standing vaccine policies.

It is also the first meeting since ACIP chair Martin Kulldorff, a former Harvard Medical School professor, accepted a permanent job at HHS. Pediatric cardiologist and former U.S. Air Force flight surgeon Dr. Kirk Milhoan will lead the committee during this session.

Hepatitis B: CDC Vaccine Advisory Committee Meeting

The latest battle in the US’ growing political, cultural, and scientific debate over vaccines will unfold inside a CDC meeting room in Atlanta later this week.

There, a key CDC advisory group — now entirely appointed by Kennedy who will vote on proposals that could significantly change long-accepted guidance meant to shield newborns from hepatitis B, a virus known to cause liver cancer.

The two-day ACIP meeting comes shortly after Kennedy instructed the CDC to alter language on its website, downplaying the agency’s long-standing statement that vaccines do not cause autism, even though extensive research has repeatedly found no connection.

Here is what public health experts say they will be watching during this week’s meeting, which will be livestreamed on Thursday and Friday.

Hepatitis B: Votes May Delay Or Limit Babies’ Protection Against Hepatitis B

According to the meeting agenda, Thursday’s discussions and votes will centre on major changes to hepatitis B guidance. Overnight, the committee released draft wording for two recommendations.

As per CNN, the first proposal would shift the current universal recommendation for newborn hepatitis B vaccination to an “individual-based decision” made by parents and a healthcare provider for babies born to mothers who test negative for the virus or whose status is unknown.

The language also gives parents and clinicians the freedom to “decide when or if their child will begin the HBV series.”

The second vote concerns draft wording that encourages parents to talk with clinicians about blood tests to check immunity levels before later hepatitis B doses. The draft states that insurance should cover these tests.

Currently, all newborns are advised to receive the vaccine shortly after birth to protect against infection from an undetected maternal case and from close contacts who may unknowingly carry the virus.

Committee members have previously urged better hepatitis B screening during pregnancy, while others have questioned whether only high-risk infants should get the vaccine.

Hepatitis B: How Contagious Is It?

Hepatitis B is highly contagious. It spreads through contact with infected blood and bodily fluids, often from people with no symptoms. While it can be passed during birth, through sex, or shared needles, it can also spread through shared items found in many homes: nail clippers, toothbrushes, and even certain pieces of jewellery.

Childhood And Adolescent Immunisation Schedule

It is not yet clear what parts of the schedule will be reviewed. The early agenda listed this topic for Friday without details. The final agenda shows that attorney Aaron Siri, a close adviser to Kennedy, will speak on this.

Critics, including Kennedy, have raised questions about the number of vaccines children receive and the timing between doses.

Discussion of “Adjuvants And Contaminants” In Vaccines

According to ABC News, the draft agenda included a Friday session on adjuvants and contaminants. The final programme describes the talk as examining aluminium exposure from vaccines before 24 months and rates of persistent asthma between ages 24 and 59 months.

Aluminum salts are used in several vaccines — including diphtheria, tetanus, acellular pertussis, hepatitis A, and hepatitis B—to strengthen the immune response, according to CNN.

The ACIP meeting also follows last week’s internal FDA memo claiming that Covid-19 vaccines may be connected to the deaths of ten children. Lakshmanan, O’Leary, and others say the committee could raise the issue during the discussions.

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Donald Trump’s Health Back In Spotlight After He Seems To Doze Off In Cabinet Meeting

Updated Dec 4, 2025 | 07:00 PM IST

SummaryDonald Trump’s health is under fresh scrutiny after he appeared drowsy during a three-hour Cabinet meeting, only days after revealing his second MRI results of the year. New footage, online debate, and the White House’s response have renewed questions about the 79-year-old president’s fitness.
donald trump sleeps cabinet meeting

Credits: AP

US President Donald Trump was seen struggling to stay alert several times during a three-hour Cabinet meeting on Tuesday. Footage showed the 79-year-old president narrowing his eyes again and again and briefly closing them fully, even as Cabinet officials spoke about their work and praised his leadership.

At one point, he appeared to drift off while Commerce Secretary Howard Lutnick addressed the room before shifting forward to reply. His tired look followed a long night on Truth Social, where he posted more than 160 times between 7 p.m. and midnight on Monday and resumed posting shortly before 6 a.m. on Tuesday, which added to the growing discussion around his health.

Donald Trump Appears to Fight Sleep During Televised Cabinet Meeting

President Donald Trump seemed to lose focus multiple times during the Dec. 2 Cabinet meeting. He repeatedly narrowed his eyes and, at one moment, kept them fully closed as his team outlined their achievements and spoke in his praise. While Howard Lutnick shared an update on the Commerce Department, Trump kept his eyes shut for several seconds before leaning in to answer him.

The president’s drained appearance followed a night of heavy activity on Truth Social, where he uploaded more than 160 posts from early evening to midnight on Dec. 1. He returned to the platform by 5:48 a.m. the next morning.

When PEOPLE reached out for comment, the White House shared a statement from press secretary Karoline Leavitt. She said, “President Trump was listening closely and leading the three-hour Cabinet meeting,” before repeating a recent administration claim that Somali immigrants do not belong in Minnesota.

She continued, “Watch his strong closing remarks in the press conference, where he called out America-Last Democrats for allowing radical Somali migrants to take advantage of American taxpayers.” She said that this moment captured the energy of Trump’s ninth Cabinet meeting of his second term, all of which have been fully open to the press.

“In each of these meetings,” she added, “the President and his team lay out the long list of accomplishments they have delivered for the American people to Make America Great Again.” Last year, Trump rejected reports that he had fallen asleep during his criminal trial in New York. Multiple outlets had described him slipping into brief naps, with The New York Times noting, “Mr. Trump appeared to nod off a few times, his mouth going slack and his head drooping onto his chest,” which Trump denied.

Donald Trump Health Questions Surge As He Was Caught Sleeping

Donald Trump is once again facing scrutiny over his health after a new video showed him looking sleepy during a Cabinet meeting. His slow eye movements and long pauses with his eyes shut set off fresh conversations online. A separate photograph from Mar-a-Lago, where he appeared with his eyes closed and mouth open, fuelled more worry.

As per PEOPLE, at the same time, an image of Joe Biden looking lively during a walk in Nantucket led to a wave of side-by-side comparisons on social media. The White House maintains that Trump remains in “excellent health”, pointing to recent tests, though his unclear remarks about undergoing an MRI have added to public questions. With both leaders under a microscope, discussions about presidential fitness have returned with new intensity.

Donald Trump MRI Scan Results

The White House on Monday released details from Donald Trump’s MRI, which he completed last month as concerns about his health continued. In a statement, Navy Captain Sean Barbabella, the physician to the president, outlined the results of Trump’s advanced imaging. He said the scan focused on Trump’s heart and abdominal region, showed no issues, and confirmed that the president is in “excellent health”. This type of preventive testing is common for men in his age group.

Even so, with this being his second MRI this year, speculation has grown about whether Trump is dealing with any health problems, and the recent moment where he seemed to fall asleep has heightened that speculation.

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