In a significant shift, the US Food and Drug Administration (FDA) has announced its plan to reduce its reliance on animal testing for drug development. This is especially for monoclonal antibody therapies and other advanced medicines. The agency now plans to use more human-relevant technologies in order to improve safety, lower costs and also speed up the approval process.

Animal History Traces Back To Ages

Animal testing has remained the cornerstone of all experiments, whether medicine or space. Since the 1930s, when the US passed the Federal Food, Drug, and Cosmetic Act in response to the tragic consequence of untested medication, animal testing was mandated. Scientists have been using mice, rats, rabbits and other animals to test for toxicity, side effects, as well ass efficacy before any new drug could be forwarded for human trial.

Over the decades, this practice also helped introduce many life-saving treatments. However, it has also raised ethical concerns and scientific questions, especially on how accurately can animal models really predict human response.

Why Is FDA Now Moving Away From Animal Testing?

The FDA’s new initiative represents a "paradigm shift," according to its Commissioner, Dr. Martin A. Makary. There are several reasons behind this change:

Limited Predictive Value: Drugs that work safely in animals don’t always perform the same way in humans. This mismatch can lead to failed clinical trials or unexpected side effects in people.

Ethical Concerns: As public awareness and concern about animal welfare have grown, so too has the demand for more humane research methods.

Cost and Time: Animal testing is expensive and time-consuming. Each stage of testing can take months or years and cost millions of dollars.

Scientific Advancements: New technologies now offer better ways to model human biology and disease. These methods not only spare animals but also yield more accurate data.

What Can Replace Animal Testing?

The FDA is planning to incorporate innovative tools like computer modeling and AI, human organoids, and organ-on-a-chip technology, as well as real world human data.

How Will these Work? The computer modeling and AI will allow the scientists with the help of simulations to predict how a drug will behave in the human body based on its chemical structure, genetics, and existing medical data.

Furthermore, human organoids are miniature, lab-grown versions of human organs like a liver or brain which are made from stem cells. They also closely mimic how real organs function and could be used to test drug safety and effectiveness.

Organ on a chip technology involves tiny chips that simulate the activity of the entire organ systems. For instance, how the heart beats or the lungs breathe. It allows for more accurate and efficient testing.

The agency is also planning to rely more on existing human clinical data from other countries with comparable regulatory standards. If a drug has already been tested and used abroad, repeating animal testing for the same in the US should not be any longer a mandate.

The new approach will be applied immediately to investigational new drug applications—essentially, the first step in bringing a new treatment to the U.S. market. This means that pharmaceutical companies can now submit non-animal safety data as part of their applications.

Importantly, this doesn’t mean animal testing will be banned entirely. In some cases, it may still be required to answer specific safety questions. However, the goal is to make animal studies the exception, not the rule.

Cancer is an umbrella term for abnormal excess growth that can occur in any part of the body. Leukemia is the cancer of blood, which means there is rapid growth of abnormal blood cells. This growth starts in the bone marrow, which is where your body makes blood. The Cleveland Clinic explains that unlike other cancers, leukemia does not form a mass or tumor that can be detected in a CT scan.

The usual treatment of Leukemia involves Chemotherapy, whether by pill, injection into your vein or a shot under your skin. Another treatment for it is immunotherapy which uses a drug to boost your body’ defense system so that it can fight the cancer itself. Now, a research by American Association for Cancer Research April 2025, has revealed that a pre-made version of immunotherapy can effectively fight blood cancers. This "off-the-shelf" approach offers a potentially faster and easier way to deliver this powerful therapy to patients in need.

Promising Treatment Against Blood Cancer

This new way to treat blood cancer uses special immune cells called natural killer cells, or NK cells. These NK cells have been changed in a lab to have special tools, called CARs, that help them find and kill cancer cells. What's really helpful is that these CAR NK cells can be made ahead of time from healthy people and stored. This means doctors can just take them off the shelf and give them to patients who need them quickly, without having to wait for a treatment to be made just for them, making the whole process much simpler and faster.

The results from using this ready-made CAR NK cell treatment yielded promising results, especially for people with a type of blood cancer called acute myeloid leukemia, or AML. The scientists found that after getting this treatment, some of the patients with AML had their cancer completely disappear. This is called complete remission, and it means there were no signs of cancer left in their blood. These early successes give a lot of hope for a new and better way to treat this difficult disease.

Notably, AML is a very fast-growing and serious cancer. According to American Cancer Society this cancer develops in the myeloid cell, the cells that would normally become white blood cells. This type of cancer develops quickly, hence needs to be treated with the same urgency.

Who Does This Treatment Help?

The first group of patients who received this ready-made CAR NK cell treatment were people whose leukemia had either stopped responding to other treatments or had come back after treatment. These are often the most difficult cases to treat. The fact that some of these patients had such a good response to the SENTI-202 treatment, which is a safety feature to the SENTI-202 cells. It's like a special switch that stops the NK cells from attacking healthy cells in the body. With their cancer completely disappearing, is a very encouraging sign that this new approach could offer hope to patients who have run out of other options.

More Research Needed To Confirm Safety and Effective

The researchers are hopeful about the new treatment and early success for the treatment. They believe that this ready-made approach could lead to new types of immune therapies that are much easier to produce and give to patients. Researchers emphasized that there's a big need for better treatments for AML, and he hopes this new method can become an important option for these patients who often have very limited choices.

It's important to remember that these are just the first results from an ongoing study. The scientists are still enrolling more patients to learn even more about how safe and how well SENTI-202 works. They need to keep studying it to make sure it's a reliable and effective treatment for more people with blood cancers. Before this treatment can be used widely, the findings need to be carefully reviewed and published in a scientific journal.

The uncertainty around the Novavax's COVID-19 vaccine has been exacerbated by the Trump administration. The new government has imposed new requirements on the nation's only traditional protein-based vaccine. These new requirements have led to many confusions about vaccine updates, including other vaccines too, which await approval.

The Wait For Full Approval Is Too Long

Novavax is the maker of the protein-based COVID-19 vaccine, which was on track to receive full approval from the US Food and Drug Administration (FDA) by April 1. However, the approval process was paused because of Dr Sara Brenner, the FDA's acting commissioner. The reason for delay has raised many questions about the interference, including political, especially after Dr Peter Marks, FDA's longtime vaccine chief had left following disagreements with Health Secretary Robert F Kennedy Jr. These events have further led to the apprehensions of uncertainty regarding the vaccine's future.

As of now, Novavax's vaccine is only authorized for emergency use. Unlike mRNA vaccines form Pfizer and Moderna, which have full approval, the Novavax vaccine holds the EUA or the Emergency Use Authorization, which allows it to be distributed during public health emergencies. However, once the emergency ends, the FDA can remove these vaccines from market unless full approval is granted.

What Caused The Delay?

The FDA had initially planned to approve Novavax's vaccine by its April 1 target date. However, sources familiar with the situation revealed that Trump appointees influenced the delay. Since then, Novavax has been in discussions with the FDA to determine additional requirements for approval. In the meantime, the FDA's recent comments have fueled concerns that Novavax’s vaccine may be treated as a “new product” due to its updates to match last year’s coronavirus strain. This would require new clinical trials, a process unlikely to be completed before the fall.

ALSO READ: Novavax Says FDA Approval Back on Track for Its COVID Vaccine

This approach to Novavax’s vaccine approval stands in stark contrast to the FDA’s treatment of the mRNA vaccines, where annual strain updates have been handled in a way similar to flu vaccines, requiring only small-scale tests to demonstrate the vaccine’s continued effectiveness against new strains. Dr. Paul Offit, a vaccine expert, argued that it would be unnecessary to treat these annual updates as “new products” requiring full trials, as long as the updated vaccines show that they produce protective antibody levels.

Role Of HHS Secretary

Of course Robert F Kennedy Jr will have a role to play, being the Health Secretary, and a known vaccine skeptic. Despite claiming in recent speeches that he is not anti-vaccine, Kennedy’s past associations with anti-vaccine groups have raised alarms. His nonprofit, Children’s Health Defense, has been involved in campaigns questioning vaccine safety, and Kennedy himself has made public statements suggesting that vaccines can cause autism—a long-debunked claim.

His actions have also contributed to the uncertainty that surrounds the Novavax's approval today and the overall direction of US vaccine policies.

Is Novavax Different From Other Vaccines?

What sets Novavax apart from other COVID-19 vaccines is its traditional approach. While Pfizer and Moderna’s mRNA vaccines use genetic instructions to create a temporary version of the virus’ spike protein, Novavax’s vaccine contains lab-grown copies of the spike protein itself. This approach has been used for decades in vaccines for diseases like hepatitis B and shingles, making it a more familiar method for people who may be hesitant about mRNA vaccines.

Danish multinational pharmaceutical company Novo Nordisk has launched Wegovy in Thailand, marking the entry of its hugely popular weight loss drug in Southeast Asian market. First launched in 2021, Wegovy helped make Novo Nordisk Europe's most valuable listed company until recently, worth $615 billion at its peak. Wegovy is a semaglutide shot, which means that it is a GLP-1 receptor agonist.

"We actually received the Thai FDA approval already in 2023," said Enrico Canal Bruland, vice president and general manager of Novo's Thai subsidiary. He noted that Novo was making Wegovy available in Thailand ahead of rival Eli Lilly's Zepbound. Wegovy is currently available for prescription in private hospitals around the country and will be available soon in public hospitals. Notably, Bruland declined to provide details on Wegovy's pricing in Thailand, which has a population of around 66 million, or Novo Nordisk's plans for expansion into other Southeast Asian markets.

Notably, the most popular GLP-1 agonist Ozempic was also created by Novo Nordisk. Earlier this month, the pharma giant expanded its research in the field diabetes and weight loss drug and announced that its diabetes pill, Rybelsus, demonstrated cardiovascular benefits in a late-stage trial. The findings pave the way for the medication to become a new treatment option for people living with both diabetes and heart disease.

How Do Semaglutides Work?

Semglutide is the synthetic version of GLP-1—a natural hormone produced in the intestines that regulates blood sugar, appetite, and digestion. Now, every time you eat, your body produces various hormones, including GLP-1. These are called Post nutrition hormones, and help you absorb the energy you just consumed.

GLP-1 travels to your pancreas, prompting it to produce insulin. It also travels to the hypothalamus in your brain, which gives you the feeling of being full or satiated. Ozempic imitates this hormone, thereby, silencing the food chatter in the brain. Interestingly, for some people this food chatter is really quiet ( people with low appetite) and for others it is an outbrurst, (people who generally binge eat.) So with Ozempic, silencing this self-talk in the brain, people tend to lose their appetite and eventually weight.

However, it is important to note that losing weight includes not just fat but muscle as well. Losing too much muscle can lead to reduced strength and a shorter life span. Notably, records show that most people who start taking them stop it at 12 weeks; therefore, it is important for some but not for others.

Notably, last month, US pharma major Eli Lilly launched the obesity management drug Mounjaro in India at one-fifth of the US price. The company rolled out the drug in a single-dose vial following the marketing authorisation from the Central Drugs Standard Control Organization (CDSCO). It has been priced at Rs 3,500 for a 2.5 mg vial and Rs 4,375 for a 5 mg vial. "It is a first-of-its-kind treatment for obesity, overweight, and type 2 diabetes that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors," the company said.