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 To Hold Psychedelic Drug Hearing Amid Trump Push: What It Means For Depression, PTSD

Updated Sep 14, 2026 | 11:27 PM IST

Summary​Emerging research shows psychedelics can help improve mental health, especially in conditions where traditional treatment approaches have not been useful. However, these drugs also come with several health risks that cannot be overlooked.​​
US FDA To Hold Psychedelic Drug Hearing Amid Trump Push: What It Means For Depression, PTSD

Credit: iStock

The US Food and Drug Administration (FDA) has announced to hold a public hearing on the potential therapeutic use of psychedelic drugs, as the Donald Trump administration pushes to accelerate research and development of these treatments for serious mental illnesses.

The hearing, it said, will examine their potential use in supervised and supportive settings, including patient safety, provider training, access and data collection.

In a statement, the FDA said it is collaborating with federal partners and holding “this public hearing to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings”.

What Will The FDA Hearing Discuss?

Also read: Ibogaine: Why Donald Trump Is Pushing US FDA To Fast-track This Psychedelic

The hearing will focus on what would be needed for the potential therapeutic use of psychedelic drugs in supervised and supportive settings.

Key areas include:

  • Provider training and credentialing
  • Patient safety
  • Access to treatment
  • Data collection and standardization

Emerging research shows psychedelics can help improve mental health, especially in conditions where traditional treatment approaches have not been useful. However, these drugs also come with several health risks that cannot be overlooked.

The hearing is part of broader US efforts to increase clinical trial participation, data sharing and real-world evidence on psychedelic drugs. The FDA hearing does not amount to approval of psychedelic treatments. Instead, it could help shape how the US approaches their potential future use in medical care.

What Does This Mean For Depression And PTSD?

The FDA has already taken steps to speed up the development of psychedelic treatments for mental health conditions.

In April 2026, the agency issued national priority vouchers to companies studying psilocybin for treatment-resistant depression (TRD), psilocybin for major depressive disorder (MDD), and methylone for post-traumatic stress disorder (PTSD).

The FDA has also granted Breakthrough Therapy designation to psychedelic drug programs involving MDMA for PTSD and psilocybin for TRD and MDD.

Research over the past decade has suggested that MDMA-assisted therapy may help reduce PTSD symptoms, while psilocybin-assisted therapy has shown promise for treatment-resistant depression in clinical studies.

For people who do not get lasting relief from existing treatments such as antidepressants and psychotherapy, psychedelic-assisted therapy could potentially offer another treatment option.

However, these designations and regulatory steps do not mean that these drugs have been approved as safe or effective treatments. Neither a national priority voucher nor Breakthrough Therapy designation is a substitute for FDA marketing approval.

Read More: Psychedelic Compound Found In 'Magic Mushrooms' May Help Prevent Painful Chemotherapy Side Effects, Study Finds

Why Is The US Accelerating Psychedelic Research?

The push has expanded beyond the FDA. In 2026, the White House, Congress and the Department of Veterans Affairs (VA) have also become involved in efforts to accelerate research into psychedelic treatments, including psilocybin, MDMA and ibogaine.

The US Department of Health and Human Services (HHS) has partnered with the VA to accelerate the development of psychedelic-assisted therapies for veterans with conditions including PTSD, depression and traumatic brain injury.

Separately, a bipartisan group of lawmakers introduced a bill that would require the US Department of Defense to evaluate whether ongoing psychedelic research, particularly involving psilocybin, could benefit active-duty service members and veterans transitioning to civilian life.

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1,370 Mpox Cases, 7 Deaths Reported In July: WHO Says Risk Remains Moderate

Updated Sep 14, 2026 | 09:39 PM IST

SummaryFrom January 1, 2025, to July 31, 2026, a total of 65,784 mpox cases and 264 deaths were reported across 105 countries.​The WHO Director-General's standing recommendations on mpox have been extended until August 2027.
1,370 Mpox Cases, 7 Deaths Reported In July: WHO Says Risk Remains Moderate

Credit: iStock

A total of 1,370 mpox cases and seven deaths were reported globally in July, according to the World Health Organization (WHO), which continues to assess the global public health risk from the multi-country outbreak as moderate.

The WHO external situation report, published today, is based on data from 32 countries across four WHO regions. The case fatality ratio (CFR) was 0.5%.

About three-quarters of the cases were reported in the WHO African Region.

Madagascar Reports Highest Cases

Madagascar reported the highest number of cases, with 703 cases and seven deaths, followed by Angola (138), China (88), the Democratic Republic of the Congo (85) and Kenya (55).

Between July 6 and August 16, Madagascar reported 785 cases, while deaths remained at seven. Angola reported 184 cases, Kenya 94, the Democratic Republic of the Congo 41 and Cameroon 28.

The WHO noted that Congo's figures may be affected by delays in mpox reporting as the country focuses on its response to the Bundibugyo virus disease outbreak.

65,784 Mpox Cases Reported Since January 2025

From January 1, 2025, to July 31, 2026, a total of 65,784 mpox cases and 264 deaths were reported across 105 countries.

“WHO conducted a global mpox rapid risk assessment in August 2026; the overall global public health risk associated with the mpox multi-country outbreak was again assessed as moderate,” the WHO said.

“WHO continues to consider the ongoing multi-country mpox outbreak a graded emergency, with new outbreaks reported in multiple countries and over a thousand confirmed cases reported every month,” it added.

The WHO urged countries and partners to maintain mpox surveillance, notification and coordinated preparedness and response activities.

The WHO Director-General's standing recommendations on mpox have been extended until August 2027.

Clade Ib Mpox Spreads

Mpox transmission continues to affect key populations, largely through sexual transmission, followed by household spread and community outbreaks. All clades of monkeypox virus (MPXV) continue to circulate.

In July, the African Region reported more confirmed cases than in June, while the Americas, Western Pacific, European and South-East Asia regions reported fewer cases. The Eastern Mediterranean Region reported no confirmed cases.

Eleven African countries reported active transmission between July 6 and August 16, with 1,153 confirmed cases and seven deaths.

Chile and Hungary reported clade Ib MPXV for the first time. Several European countries, including the UK, have reported community transmission of clade Ib.

Mpox Vaccine Shows Promising Early Results

The first human trial of BNT166a, an mRNA-based mpox vaccine developed by BioNTech, showed encouraging early results.

The vaccine was generally safe and well tolerated and triggered strong antibody responses across all dose levels, including in people who had and had not previously received vaccination against related viruses.

The trial involved 64 adults and was primarily designed to assess safety and immune responses, rather than whether the vaccine prevents infection.

“These findings are an important step forward in the development of a new generation of vaccines against mpox. We’ve shown that this mRNA vaccine approach can safely generate strong immune responses in people, which is very encouraging," said Professor Saul Faust, UK Chief Investigator for the trial.

The vaccine is now progressing to a larger trial to assess its effectiveness in real-world settings.

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Lung Cancer: 2 Drugs From GSK, BioNTech Show Improved Survival, 94% Response

Updated Sep 14, 2026 | 08:00 PM IST

SummaryIn 2022, lung cancer was the leading cause of cancer death, with an estimated 2.5 million cases and 1.8 million deaths. Lung cancer occurs when abnormal cells grow uncontrollably in the lungs. Treatment depends on a person's medical history and the stage of the disease.
Lung Cancer: 2 GSK, BioNTech Drugs Show Survival, 94% Response

Credit: iStock

Lung cancer is the leading cause of cancer cases and deaths worldwide, with an estimated 2.5 million new cases and 1.8 million deaths in 2022.

Lung cancer is often diagnosed at later stages, when five-year survival rates are lowest. Now, two drugs developed by pharma giants GSK and BioNTech have shown promising results in major clinical trials.

Data presented at the ongoing International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea, showed that the drugs could improve survival and produce high tumour response rates in patients with certain types of non-small cell lung cancer (NSCLC).

GSK's Jideytro Shows 94% Response Rate

GSK announced positive results from the ARROS-1 trial evaluating Jideytro (zidesamtinib) in patients with ROS1-positive NSCLC who had not previously received treatment with a tyrosine kinase inhibitor.

Among patients who had not previously received a tyrosine kinase inhibitor (TKI), an oral targeted therapy, Jideytro triggered an objective response in 88 patients, giving an objective response rate of 94%.

These patients were allowed to have received up to one prior line of chemotherapy, with or without immunotherapy, before entering the study.

GSK reported that 90% of patients remained progression-free at 12 months. Notably, 70% of patients with brain metastases saw complete clearance of detectable tumors.

With the promising results, the company said it will apply for a supplemental New Drug Application to the US Food and Drug Administration later this year to expand Jideytro's approval into first-line use.

Jideytro was already approved in July 2026 for previously treated patients with advanced ROS1-positive NSCLC.

BioNTech Drug Nearly Doubles Survival

German biopharmaceutical company BioNTech said its experimental immunotherapy gotistobart (BNT316/ONC-392) produced a significant overall-survival benefit in the Phase 3 PRESERVE-003 trial in previously treated metastatic squamous NSCLC.

Gotistobart is an investigational immunomodulator that targets CTLA-4 and is designed to selectively enhance regulatory T-cell depletion in the tumor microenvironment.

According to the company, median overall survival was 18.5 months with gotistobart, compared with 10.0 months with standard-of-care docetaxel chemotherapy, nearly doubling median survival in this patient population.

The findings suggest potential for gotistobart as a chemotherapy-free treatment approach in previously treated patients with squamous NSCLC.

“The magnitude of the survival benefit observed with gotistobart as a chemotherapy-free treatment approach in the PRESERVE-003 clinical trial is highly encouraging. If confirmed in the pivotal portion of the Phase 3 trial, these findings could transform the standard of care in a setting where new therapies are urgently needed,” said Rama Balaraman, Principal Investigator and medical oncologist at Ocala Oncology Center, Florida, US.

What Is Lung Cancer?

Lung cancer is a serious disease and remains a major public health challenge worldwide due to its high incidence and mortality.

Lung cancer occurs when abnormal cells grow uncontrollably in the lungs. Treatment depends on a person's medical history and the stage of the disease.

The two main types of lung cancer are non-small cell lung cancer (NSCLC), which accounts for around 85% of cases, and small cell lung cancer (SCLC), which is less common but typically more aggressive.

With a five-year relative survival rate of 15% and a median overall survival of 11 months in the United States between 2000 and 2017, squamous NSCLC is a devastating disease with limited treatment options.

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