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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Taiwan FDA Recalls 87,000 Blood Pressure Tablets: Here’s Why The Medicine May Not Work As Intended

Updated Aug 13, 2026 | 01:30 PM IST

SummaryTaiwan’s Food and Drug Administration recently recalled a batch of a popular blood pressure medication after it failed an important quality test.
Taiwan FDA Recalls 87,000 Blood Pressure Tablets: Here’s Why The Medicine May Not Work As Intended

Credit: AI

Taiwan’s Food and Drug Administration (TFDA) has recalled of 87,360 tablets of a blood pressure medication after a specific batch failed a quality test. Health officials raised concerns, saying that the drug may not work as effectively as expected.

The recall involves Beniel F.C. Tablets 8 mg, manufactured by Synmosa Biopharma Corp. The affected batch is 2KA31, and the medicine contains benidipine hydrochloride, a drug used to treat high blood pressure.

Why Has The Blood Pressure Medicine Been Recalled?

The problem was first identified during a stability test of the drug, which found that the tablets failed to meet the required dissolution standards.

In simple terms, a dissolution test is conducted to check how a tablet breaks down and releases its active ingredient under controlled conditions.

This is an important test as a tablet has to release the medicine in the proper way for the body to absorb it and for the drug to produce its intended effect.

Also read: Blood Pressure, Heart Medicines May Boost Effectiveness Of Antidepressants, AIIMS Study Finds

What Is Benidipine And How Does It Work?

Benidipine hydrochloride belongs to a group of drugs called calcium channel blockers. These medicines help lower blood pressure by relaxing and widening blood vessels. This enables the blood to flow more easily and reduces the pressure against artery walls.

That is why a problem affecting how a tablet dissolves can matter. If the active ingredient is not released into the body as expected, the medicine may not deliver its intended therapeutic effect.

Also read: Why Are More Women Under 35 Reporting Heart-Related Symptoms?

Is There A Risk Of Medicine Shortage?

According to the TFDA, there is no immediate concern of medication shortage. Other batches of Beniel F.C. Tablets 8 mg are not affected, and the manufacturer has sufficient inventory.

Production of the drug will also not been stopped. Taiwan News reported that two other products containing the same active ingredient are also authorised for sale.

The manufacturer has been ordered to complete the recall by August 24 and submit an investigation report along with corrective and preventive measures for future production.

Also read: Smoking, Diabetes, High Blood Pressure May Fuel the Most Dangerous Type of Artery Plaque, Study Finds

What Should Patients Taking Medicine From Recalled Batch Do?

Patients should not stop their blood pressure medication on their own. The TFDA advised people who are concerned about their prescription to speak with their doctor about whether an alternative medicine is necessary.

The recall highlights an often overlooked part of medication safety: a medicine can contain the correct active ingredient but still fail a quality test if its physical properties affect how the drug is released. For now, the concern is focused on one specific batch, rather than the entire Beniel F.C. product line.

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Ebola 2026 Outbreak Spreading Faster Than Any Before, On Track To Become Deadliest: WHO Chief

Updated Aug 13, 2026 | 12:17 PM IST

SummaryDespite the challenges, Dr Tedros said significant progress has been made, with 886 patients recovering. Two vaccines specifically designed against the Bundibugyo virus have also entered Phase 1 safety trials in humans for the first time.
Ebola 2026 Outbreak Spreading Faster Than Any Before, on Track to Become Deadliest: WHO Chief

Credit: AP Photos

The ongoing Ebola virus disease epidemic in the Democratic Republic of Congo (DRC) is moving faster than any previous outbreak, said WHO chief Dr Tedros Adhanom Ghebreyesus.

According to official data, confirmed cases have reached 4,449, with the death toll climbing to 2,061 across five provinces and 53 health zones in the country. However, the number of uncounted cases may be far higher than the reported figure.

“It is already the second-biggest Ebola epidemic on record, and it is moving faster than any previous Ebola outbreak. At its current pace, it is on track to eclipse the West African Ebola outbreak of 2014 to 2016,” Tedros said in a briefing.

The 2014-2016 outbreak reported at least 28,000 cases and took about eight months to reach 1,000 deaths.

Ebola 2026: Big Head Start, Likely to Peak in 6 Months

Tedros noted that the current “outbreak had a big head start, it is still way ahead of us, and we are playing catch-up.”

He said this even as reports showed that the disease caused by the rare Bundibugyo virus had been circulating since February and went undetected for months. The WHO declared the outbreak on May 15.

Dr Abdirahman Mahamud, WHO’s director for health emergency alert and response operations, said the agency expects the outbreak to reach its peak within six months, AP News reported.

“But ... that’s the moderate scenario,” Mahamud said. “There is a one-case scenario where this outbreak may last nine months to 12 months.”

Also read: Ebola Death Toll Tops 2,000 In DRC: New Study Reveals Likely Source Of Bundibugyo Virus Outbreak

Unknown Chains of Transmission

Tedros said about 90% of all cases and 80% of deaths are in the province of Ituri, with sustained transmission in the towns of Bunia, Rwampara, Nizi and Lita.

“Most concerningly, we see a high proportion of deaths in communities instead of treatment units, outside of known contact lists,” Tedros said.

“That tells us there are chains of transmission we don’t know about, and until we know about – and break – every chain of transmission, we will not stop the outbreak.”

Most transmission happens when people have late-stage disease and are not in treatment, or when their bodies are handled after death.

Early clinical care and safe and dignified burials are therefore critical for interrupting transmission. Both depend on the trust of affected communities, making community engagement and ownership essential.

“There is no other way,” Tedros said, adding that the response is now being scaled up, with the primary goal of interrupting transmission.

With partners, WHO is mapping and pooling resources to strengthen community-based surveillance, bring every suspected case into care and reach the 95% contact-tracing target needed to interrupt transmission. Currently, the rate is around 80%.

Read More: Ebola Outbreak: Officials To Probe Whether Bundibugyo Virus Is Mutating

Progress Made

Despite the challenges, Tedros said significant progress has been made, including:

  • More than 21,000 community health workers have been trained.
  • Treatment centres, safe burial teams, laboratories and community engagement teams are operating across the affected provinces, reaching hundreds of thousands of people.
  • A total of 886 patients have recovered, even without specific therapeutics and vaccines, which are progressing through trials.
  • For the first time, two vaccines specifically designed against Bundibugyo virus have entered Phase 1 safety trials in humans.
  • Two new animal studies of a vaccine against Zaire ebolavirus — the more common species — have shown promising evidence of cross-protection in animals, Tedros said.

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‘Entirely Unverified Retatrutide’ Being Sold on Black Market: Lilly Sues 6 US Companies

Updated Aug 12, 2026 | 10:56 PM IST

SummaryThe drugmaker noted that it has reported more than 14,000 websites, advertisements, social media posts and product listings that allegedly market retatrutide unlawfully across more than 100 countries to internet service providers, social media platforms and e-commerce companies.
‘Entirely Unverified Retatrutide’ Being Sold on Black Market: Lilly Sues 6 Companies

Credit: iStock

American drugmaker Eli Lilly has sued six companies in the US over the alleged illegal sale of its experimental weight-loss drug retatrutide.

In a statement, Lilly said that the lawsuits target US entities allegedly selling illegal retatrutide products, claiming that their products are for “research use only” while allegedly marketing them for human use. These include

  • compounding pharmacies,
  • medical spas
  • online sellers.

“Retatrutide is being rigorously studied as part of a comprehensive clinical trial development program,” said David A. Hyman, Lilly’s chief medical officer.

“We take the responsibility of evaluating the safety and efficacy of our investigational medicines seriously. What is being sold on the black market is not a medicine – it is entirely unverified, unapproved and not worth the risk,” he added.

Which Six Companies Is Lilly Suing?

Lilly has filed lawsuits against:

  • Aesthetic Envy Cosmetic Centers LLC, doing business as Aesthetic Envy
  • Astra LLC, doing business as Astra Peptides
  • Legendary Peptides, LLC
  • Striker Pharmacy, LLC
  • Texas Peptides Inc
  • Lone Star Peptide Co

Black-Market Retatrutide

Lilly said it has referred more than 200 individuals and entities to the US Food and Drug Administration (FDA), the US Department of Justice, state attorneys general, law enforcement agencies and professional licensing boards.

The company is also working with regulators, law enforcement and customs authorities worldwide to address the illegal market.

Lilly urged social media and e-commerce platforms, credit card companies, payment processors, and shipping and logistics companies used by sellers to help protect patients and tackle the illicit activity.

The drugmaker noted that it has reported more than 14,000 websites, advertisements, social media posts and product listings that allegedly market retatrutide unlawfully across more than 100 countries to internet service providers, social media platforms and e-commerce companies.

FDA Says Unapproved Retatrutide Is Illegal

The US FDA has made clear that selling unapproved retatrutide directly to consumers is illegal. Retatrutide also cannot be lawfully compounded.

The FDA has warned that so-called “research-use only” products are of unknown quality and may pose risks to consumers’ health.

Black-market sellers and businesses posing as legitimate medical providers have openly marketed retatrutide as a weight-loss “hack.”

According to Lilly, such products are frequently made by unregulated foreign manufacturers. Regulators, customs agencies and law enforcement authorities worldwide have warned about these products and have taken actions including raiding clandestine manufacturing sites, seizing shipments and making arrests.

What Is Retatrutide?

Retatrutide is one of Eli Lilly’s next-generation obesity treatments and is currently under development. Unlike Lilly’s currently approved GLP-1 drugs, retatrutide activates three hormone receptors: GLP-1, GIP and glucagon.

Researchers believe this triple-action approach could help people lose excess weight by reducing appetite while also increasing energy expenditure.

Retatrutide Shows Promise in Trials

Retatrutide has attracted significant interest after late-stage clinical trials showed some of the highest weight-loss outcomes reported with an obesity medication. In Phase 3 studies, adults without diabetes who received the highest dose lost more than 28% of their body weight over 80 weeks.

Lilly plans to submit retatrutide for approval to the US FDA in the first quarter of 2027.

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