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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COVID Cicada Variant Unlikely To Pose Major Threat, Claims Study

Updated Apr 4, 2026 | 03:30 PM IST

SummaryWhat makes the BA.3.2 variant special is the “70 to 75 substitutions and deletions in the gene sequence of its spike protein”, according to the US CDC’s latest Morbidity and Mortality Weekly Report.
COVID Cicada Variant Unlikely To Pose Major Threat, Claims Study

Credit: Canva

The emerging COVID-19 BA.3.2 variant, dubbed Cicada and detected in 23 countries, may not pose a significant global threat, claimed a study.

The 2025 study, published in the mBio journal, showed that the immune response of the BA 3.2 COVID variant from vaccines or prior infection is less effective than against the original strain. The antibody effectiveness is three times lower against the BA.3.2 variant. However, it does not mean that there is no protection at all.

“BA.3.2 showed intermediate neutralization, representing a 3-fold reduction compared to the ancestral strain,” said the researchers from the Icahn School of Medicine at Mount Sinai, US.

“BA.3.2 occupied an intermediate but distinctly separate position,” they said, adding that the variant “shows substantial immune escape potential that threatens protection”.

In the study, the researchers used antigenic mapping to assess neutralizing antibody responses in 56 adults with varied exposure histories following KP.2 vaccination against emerging variants, including LP.8.1, LF.7.1, NB.1.8.1, XFG, and BA.3.2.

While KP.2 vaccination enhanced neutralization against homologous variants, substantial reductions in neutralizing activity were observed against emerging Omicron variants across all exposure groups.

Exposure history showed some influence on neutralization breadth, with self-reported vaccination-only participants exhibiting better cross-neutralization compared to individuals with hybrid immunity.

The findings highlight the ongoing challenge of maintaining vaccine effectiveness against evolving SARS-CoV-2 variants and argue for continuous updating of vaccines, the researchers said.

“Despite its extraordinary number of mutations, BA.3.2 is not able to overcome immunity from vaccination, finds study. Other variants were more capable of evading immunity. This indicates it is not a major real-world threat,” said Dr Rajeev Jayadevan, Ex-President of IMA Cochin and Convener of the Research Cell, Kerala, in a post on social media platform X. He was not part of the study.

What Is The BA.3.2 Variant?

Also read: COVID Variant BA.3.2 Spreads To 23 Countries: Is The Variant Under Monitoring A Cause Of Worry?

BA.3.2 is a descendant of the Omicron BA.3 lineage. It is genetically distinct from the previously circulating JN.1 lineages (including LP.8.1 and XFG).

BA.3.2 comprises two major branches, BA.3.2.1 and BA.3.2.2. BA.3.2.2 also has substitutions like: K356T, A575S, R681H, and R1162P, the CDC report said.

What makes the BA.3.2 variant special is the “70 to 75 substitutions and deletions in the gene sequence of its spike protein”, according to the US CDC’s latest Morbidity and Mortality Weekly Report.

“BA.3.2 represents a new lineage of SARS-CoV-2, genetically distinct from the JN.1 lineages (including LP.8.1 and XFG) that have circulated in the US since January 2024,” said the CDC researchers.

“BA.3.2 mutations in the spike protein have the potential to reduce protection from a previous infection or vaccination,” they added.

Cicada Variant: Increased Risks To Children

However, the new Cicada variant with around 75 genetic changes in its spike protein is likely to disproportionately affect children, as per an expert, who noted its presence in the UK.

“Some people have done analysis on this, suggesting it may be more prevalent among young children. Children get infections all the time, but this might be something to do with the fact that they have never been exposed to Covid vaccines," Prof Ravindra Gupta, of Cambridge University, who advised the UK government during the pandemic, was quoted as saying to The Mirror.

“So this is something we’re looking at in the lab to try and work out why. The problem with this is that it is an infection that spreads fast. Eventually, it ends up in someone vulnerable," he added.

Symptoms seem to be similar to those of other recent variants and include

sore throat,

cough,

congestion,

fatigue,

headache

fever.

According to the CDC, the Cicada variant is also likely to raise gastrointestinal issues such as nausea or diarrhea.

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India Passes Jan Vishwas Bill: Here’s How It Decriminalizes Health Sector, Boosts Compliance

Updated Apr 4, 2026 | 12:00 PM IST

Summary​The reforms involving 23 Ministries rationalized over 1,000 offences across 79 Central Acts. These are aimed at helping advance Ease of Doing Business and Ease of Living across sectors.
India Passes Jan Vishwas Bill: Here’s How It Decriminalizes Health Sector, Boosts Compliance

Credit: iStock

The Jan Vishwas (Amendment of Provisions) Bill, 2026, passed by both Houses of Parliament, marks a significant step towards decriminalizing the health sector by amending certain provisions and boosting compliance.

The Union Health Ministry said that the Bill reflects the Government’s commitment to fostering a trust-based governance framework and ensuring proportionate regulation by reducing the compliance burden on individuals and businesses.

The reforms involving 23 Ministries rationalized over 1,000 offences across 79 Central Acts. These are aimed at helping advance Ease of Doing Business and Ease of Living across sectors.

It makes a key shift from criminal penalties to civil penalties as well as introduces adjudication mechanisms. The amendments ensure consistency, predictability, and proportionality in enforcement, the Ministry said.

Prime Minister Narendra Modi called the passing of the Jan Vishwas Bill by the Parliament "a matter of immense delight".

"This Bill strengthens a trust-based framework that empowers our citizens. It marks the end of rules and regulations that are outdated. At the same time, it ensures speedy disposal of cases, reduces litigation burden with decriminalization," PM Modi added.

Know ALL About the Jan Vishwas Bill

  • Within the health sector, several provisions have been amended in key legislation, such as the

Drugs and Cosmetics Act, 1940 -- to substitute imprisonment with financial penalties and to introduce a structured adjudication mechanism.

Pharmacy Act, 1948 -- to modernize penalty provisions and enhance accountability through increased financial penalties for non-compliance.

Food Safety and Standards Act, 2006 -- to strengthen enforcement while ensuring that penalties are proportionate to the nature of the offence.

Clinical Establishments (Registration and Regulation) Act, 2010 - to emphasize monetary penalties for non-compliance, particularly in cases where deficiencies do not pose immediate risks to patient safety.

National Commission for Allied and Healthcare Professions Act, 2021 -- to ensure compliance with professional standards and regulatory requirements, with penalties designed to deter violations while maintaining proportionality.

  • The new Bill replaces criminal penalties, particularly imprisonment for minor procedural violations, with graded monetary penalties.
It focuses on a more facilitative regulatory framework while retaining strict action for serious violations affecting public health and safety.

The Bill introduces a civil penalty framework to reduce the burden on courts, minimize layers of litigation, and enable faster resolution of minor compliance issues.

India Passes Jan Vishwas Bill: Here’s How It Decriminalizes Health Sector, Boosts Compliance

In the case of cosmetics, minor violations (other than spurious or adulterated) will not require court intervention and can instead be addressed through a civil penalty framework.

Further, violations such as non-maintenance of documents or non-submission of information, which were earlier punishable through court-imposed fines or imprisonment, can now be adjudicated through this civil penalty mechanism.

For the first time, the Act provides for the appointment of adjudicating authorities by the Central Government and State Governments, along with a defined process involving issuance of show cause notices, provision for personal hearing, and an appellate mechanism.

Union Health Minister JP Nadda noted that the Jan Vishwas Bill, "aims to remove outdated laws, reduce unnecessary legal burdens, and create a system that responds faster to people’s needs".

"These reforms will streamline operations for Indian medical devices manufacturers, enhance global competitiveness, and align with international best practices, ultimately benefiting patients and healthcare delivery across the country," Rajiv Nath, Forum Coordinator of The Association of Indian Medical Devices Industry (AiMeD).

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Eye Drops: US FDA Recalls Over 3 Million Products Over Safety Concerns

Updated Apr 4, 2026 | 07:10 AM IST

SummaryThe FDA, in its Enforcement Reports, stated that the eye drop products were recalled due to “lack of assurance of sterility.” The FDA notice classified the action as a “Class II recall" over risks that the products can cause “temporary or medically reversible” health problems.
Eye Drops: US FDA Recalls Over 3 Million Products Over Safety Concerns

Credit: Canva

The US Food and Drug Administration has recalled over three million eye drops in the country over safety concerns.

The 3,111,072 products were manufactured by California-based K C Pharmaceuticals and were sold under names such as “Dry Eye Relief Eye Drops,” “Sterile Eye Drops,” and “Artificial Tears Sterile Lubricant Eye Drops,” according to the FDA notice.

K C Pharmaceuticals made the voluntary recall of the eye drops in early March.

The eight types of eye drop products were sold at major retailers, including CVS, Walgreens, and Rite Aid. They have expiration dates ranging from April to October.

Eye Drops: Why Are These Recalled? What Did The US FDA Say

The FDA, in its Enforcement Reports, stated that the products recalled “lack of assurance of sterility.”

While so far, there are no reports of injuries associated with the eye drops, the FDA notice classified the action as a “Class II recall.”

Class II recalls apply to products that can cause “temporary or medically reversible” health problems.

As per the FDA, "the probability of a serious health issue is remote," over these products, and that is why the recall is categorized as a Class II, USA TODAY reported

"Patients and consumers can continue using the medicine unless otherwise directed by the recalling company or FDA," the regulator said in a statement to the publication.

Also read: Can 'Eye Strain' Lead To Brain Cancer? Experts Explain

Which Eye Drops Have Been Recalled?

NBC News reported that the recalled products include:

  1. Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl oz (15 mL) bottles
  2. EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1%, and tetrahydrozoline HCl 0.05%), 0.5 fl oz (15 mL) bottles
  3. Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, and polyethylene glycol 400 1%) 0.5 fl oz (15 mL) bottles
  4. Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 fl oz (15mL) bottles
  5. Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15mL) bottles.
  6. Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles
  7. Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles.
  8. Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles.

Here’s What You Can Do Instead?

Also read: Struggling With Dry Eyes? Study Reveals Surprising Treatment- Tips To Prevent This Disease

The key to ensuring that your eyes are protected from environmental factors like the sun, dust, and dirt, especially for those who work outdoors or spend long hours on screen, is investing in good sunglasses with ultraviolet protection.

"For those who are using computers a lot, you need to blink your eyes constantly, take breaks in between, and drink a lot of water. Dehydration is also a contributing factor to dry eye," Dr Anita Sethi, who is Principal Director and HOD Ophthalmology, Max Multi Specialty Centre at Panchsheel Park.

She also recommends using zero-number protective glasses and computer glasses that can decrease strain and dry eye.

While advising people to stay away from natural remedies like turmeric or ginger put inside the eye, Dr Sethi urged people to consume more “foods rich in vitamin E, antioxidants” to maintain eye health.

“Colored vegetables and fruits, and even maintaining thyroid and vitamin D levels, because these also contribute to dry eye,” the ophthalmologist said.

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