2025's Most Influential Drug and Vaccine Approvals So Far — As Selected by GoodRx Pharmacists

The FDA approves hundreds of medications every year. Some of them are innovative medications that are the first of their kind. Others are medications that follow in the footsteps of a larger family of drugs. Many more are new generics or biosimilars that aim to offer additional savings opportunities.

Every new medication deserves its time in the spotlight. But due to the nature of a medication’s expected impact, some new FDA approvals represent especially meaningful steps forward.

Here, we’ll review some of the most influential drug and vaccine approvals of 2025 so far, all selected by GoodRx Health pharmacists. But keep in mind this isn’t an exhaustive list.

Disclaimer: While creating this list, we prioritized first-in-class medications and vaccines that are expected to have a significant impact on human health. This was defined as either the number of lives touched or the expected degree of impact for future medication recipients. We also prioritized medications with effectiveness or safety data that represent a notable advantage over other medications recommended by clinical treatment guidelines or mainstay medical organizations.

Summary of 2025 approvals

There have been several FDA drug approvals so far in 2025. Here’s a rundown of highlights from the first three quarters of the year.

Let’s review each of these medications and vaccines in more detail.

1. Keytruda Qlex

What is it: Keytruda Qlex is an immune checkpoint inhibitor that comes as a subcutaneous (under-the-skin) injection. It combines Keytruda (pembrolizumab), an immunotherapy that’s widely used to treat several types of cancer, with berahyaluronidase alfa, an ingredient that helps the medicine spread more easily throughout the body.

FDA approval date: September 19, 2025

How it’s used: Keytruda Qlex is given by a healthcare professional as a quick injection under the skin every 3 or 6 weeks. It generally treats the same solid tumors as intravenous (IV) Keytruda in adults and kids ages 12 years and older.

Why Keytruda Qlex’s approval matters

Convenience is Keytruda Qlex’s main benefit. Instead of sitting through a traditional Keytruda infusion that can take 30 minutes or more, you can now get the same medicine as a quick shot under the skin in just 1 to 2 minutes. It’s been shown to work just as well and be just as safe as the IV version. This new option may help you spend less time at the clinic.

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2. Enbumyst

What is it: Enbumyst (bumetanide) is the first FDA-approved diuretic nasal spray. It’s approved to treat edema (fluid buildup) associated with congestive heart failure, liver dysfunction, or kidney disease in adults.

FDA approval date: September 15, 2025

How it’s used: Enbumyst is a nasal spray you can give yourself to help manage edema. You can administer it once a day for a short period of time. It’s meant to be replaced with oral diuretics (water pills) once your swelling has gone down. 

Why Enbumyst’s approval matters

Edema is a common problem among people living with heart failure, liver dysfunction, or kidney disease. Diuretics can help, but they’re usually taken by mouth or given through an IV. This can delay relief since pills take time to absorb and IV treatments require a clinic visit.

Enbumyst helps offer faster, more convenient relief — even at home. It delivers the medicine through the nasal passages so it enters the bloodstream more quickly than oral diuretics. In clinical trials, it worked just as well as IV bumetanide and was absorbed more reliably than oral tablets.

3. Wegovy

What is it: Wegovy (semaglutide) is an injectable medication that’s now approved for a liver condition called metabolic dysfunction-associated steatohepatitis (MASH). Wegovy had already been approved for weight loss and lowering the risk of serious cardiovascular problems for those with a larger body size and heart disease.

FDA approval date: August 15, 2025

How it’s used: Wegovy is administered as a once-weekly under-the-skin injection. It works best when paired with routine exercise and a nutritious diet.

Why Wegovy’s approval matters

Wegovy is the first glucagon-like peptide-1 (GLP-1) receptor agonist approved to treat MASH with liver scarring. MASH is a liver condition associated with fat buildup in liver cells, which leads to inflammation and scarring. This can result in cirrhosis, liver failure, and other related issues if left untreated. 

In a large study, more people experienced reduced liver inflammation and improved scarring with Wegovy than those taking placebo. Wegovy also supports weight loss and better blood glucose (blood sugar) management, helping tackle the root cause of MASH and the harm that stems from it.

4. Ekterly

What is it: Ekterly (sebetralstat) is the first pill approved to treat hereditary angioedema (HAE) attacks. Meant for people ages 12 and older, this new option works by blocking plasma kallikrein, which helps prevent swelling from worsening.

FDA approval date: July 3, 2025

How it’s used: You’ll take 1 to 2 tablets (300 mg or 600 mg) by mouth as soon as you notice an HAE attack starting. If your symptoms don’t improve, you can take another dose 3 hours later.

Why Ekterly’s approval matters

Ekterly is a notable step forward for people living with HAE. It’s the first treatment for sudden attacks that comes as a pill (instead of an injection or IV infusion). You can take it wherever you are as soon as symptoms start to help relieve swelling and make attacks easier to manage.

5. Yeztugo

What is it: Yeztugo is a long-acting injectable medication for HIV prevention, better known as PrEP. Yeztugo is an option for adults and adolescents who are at risk of acquiring HIV and weigh at least 77 lbs (35 kg).

FDA approval date: June 18, 2025

How it’s used: Yeztugo is given as a subcutaneous (under-the-skin) injection every 6 months by a healthcare professional. You’ll also take oral Yeztugo tablets for the first 2 days of using the medication; these oral doses help your body build up an ideal amount of lenacapavir.

Why Yeztugo’s approval matters

Yeztugo marks a major advancement in HIV prevention by removing the burden of daily pill-taking. Some experts call it “the closest thing to a vaccine” in HIV prevention, and researchers believe it could significantly boost PrEP uptake among people who are at risk for HIV.

Before Yeztugo’s approval, the longest-acting PrEP option was Apretude (cabotegravir), an injectable medication given every 2 months.

Good to know: If you’re familiar with HIV medications, you may notice that Yeztugo shares an active ingredient with a different medication, Sunlenca (lenacapavir). The main difference between Sunlenca and Yeztugo is their intended use. Sunlenca is approved to treat HIV in adults with multidrug-resistant HIV; Yeztugo is approved specifically for PrEP.

6. Enflonsia

What is it: Enflonsia is a biologic medication that helps prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants.

FDA approval date: June 9, 2025

How it’s used: Enflonsia is given as a one-time injection into the muscle by a healthcare professional. It’s meant to be administered during or before a child’s first RSV season.

Why Enflonsia’s approval matters

RSV is the leading cause of hospitalizations of infants, particularly during their first RSV season. Beyfortus (nirsevimab-alip) is already available as a long-acting medication to prevent severe RSV in this group. But Enflonsia is now another option for prevention.

Like Beyfortus, Enflonsia is a monoclonal antibody — a lab-made antibody designed to bind to RSV and prevent it from entering and infecting cells. The dosage, though, is not based on body weight, which is different from Beyfortus. 

During clinical trials, Enflonsia was shown to lower the risk of RSV disease that required medical care and hospitalization for infants. It’s now an additional tool for RSV prevention in this vulnerable population.

7. Tryptyr

What is it: Tryptyr is a prescription eye drop that treats the symptoms of dry eye disease.

FDA approval date: May 28, 2025

How it’s used: You can place one drop in each eye, twice a day. Tryptyr boosts your eyes’ natural ability to produce tears, helping them stay hydrated and comfortable.

Why Tryptyr’s approval matters

Dry eye affects millions of people in the U.S., but many aren't satisfied with existing treatments. Tryptyr works differently by quickly increasing tear production, often providing relief within just 1 or 2 days. It’s a worthwhile advancement, especially if you've tried other eye drops that haven’t helped.

Tryptyr belongs to a new class of eye drops called TRPM8 receptor agonists.

8. Nucala

What is it: Nucala is a biologic medication that’s now approved for adults with chronic obstructive pulmonary disease (COPD) marked by high eosinophil counts. It was already approved for conditions such as eosinophilic asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic granulomatosis with polyangiitis.

FDA approval date: May 22, 2025

How it’s used: Nucala is given as a once-monthly, under-the-skin injection. After you’re trained on how to use Nucala, you can inject your doses at home.

Why Nucala’s approval matters

COPD is a progressive lung condition that makes breathing difficult. For some people, inflammation caused by high levels of eosinophils (a type of white blood cell) can contribute to worsening symptoms and flare-ups. Nucala is a new treatment option for this specific type of COPD. In clinical studies, Nucala significantly reduced moderate or severe COPD flare-ups in this group.

Nucala is now the second biologic for this type of COPD and the first available as a once-monthly treatment. Dupixent, the first biologic for COPD, is injected every 2 weeks.

9. Nuvaxovid

What is it: Nuvaxovid is a protein-based COVID vaccine. It’s approved to prevent COVID in adults ages 65 years and older. It’s also approved for people ages 12 through 64 years old who have at least one underlying condition that puts them at high risk for severe COVID, such as asthma, cancer, or diabetes.

FDA approval date: May 19, 2025

How it’s used: Nuvaxovid is given as an injection into the muscle by a healthcare professional, such as a pharmacist or primary care provider. The recommended timing of doses may change based on current COVID vaccine recommendations.

Why Nuvaxovid’s approval matters

The FDA first authorized the Novavax COVID vaccine in July 2022. This allowed healthcare professionals to administer the vaccine during the public health emergency without it being fully FDA approved. And while updated versions of the Novavax COVID vaccine have been authorized since then, it’s only recently been approved for use — and for a more narrow group of people.

Nuvaxovid’s FDA approval is relevant because it provides a non-mRNA protein-based vaccine option for adults 65 and older and high-risk individuals aged 12 through 64. This fills a need for those who may prefer or require an alternative to COVID vaccines that use mRNA technology.

10. Dupixent

What is it: Dupixent is a biologic medication that’s now approved for two additional uses: bullous pemphigoid (BP) and chronic spontaneous urticaria (CSU). Dupixent is already approved for several other inflammatory health conditions, including eczema and COPD.

FDA approval date: June 20, 2025 (BP); April 18, 2025 (CSU)

How it’s used: Dupixent is injected under the skin every 2 to 4 weeks, depending on what you’re using it for. You can inject your doses at home after receiving training from a healthcare professional.

Why Dupixent’s approvals matter

Dupixent has gained several new uses in recent years, expanding its reach far beyond eczema. Its uses include conditions such as asthma, COPD, and now BP and CSU.

For BP — an autoimmune, blistering skin condition — Dupixent offers a targeted option for people who may not respond to traditional therapies. Traditional BP treatments usually involve oral corticosteroids or immunosuppressants, which can carry significant side effects. Dupixent provides an alternative that may be safer and more tolerable, especially since BP primarily affects older adults.

For CSU — a skin condition that causes recurring hives, swelling, and itching for 6 weeks or longer without a known trigger — Dupixent provides another biologic alternative for those who don’t get relief from antihistamines or Xolair (omalizumab). This approval helps expand treatment options for people with persistent hives who have struggled to find effective symptom relief.

11. Blujepa

What is it: Blujepa is an oral antibiotic that treats uncomplicated urinary tract infections (UTIs) in women and girls ages 12 years and older.

FDA approval date: March 25, 2025

How it’s used: Blujepa comes as an oral tablet. You’ll take 2 tablets twice daily after meals for 5 days.

Why Blujepa’s approval matters

The go-to treatment of UTIs is an antibiotic. But there are rising concerns over antibiotic resistance — when an antibiotic is no longer effective against certain bacteria. Even so, decades have gone by since a new oral antibiotic class has been approved for uncomplicated UTIs. 

This changed in early 2025 with Blujepa, a first-in-class oral antibiotic. It has been shown to work against common UTI-causing bacteria, including those that are resistant to current antibiotics. 

One clinical trial found that Blujepa worked just as well as nitrofurantoin (Macrobid, Macrodantin), a first-choice antibiotic for UTIs. And another trial found it to be more effective.

12. Miudella

What is it: Miudella is a hormone-free copper IUD (intrauterine device). It’s a new option for birth control or contraception.

FDA approval date: February 25, 2025

How it’s used: A trained healthcare professional places Miudella into the uterus during an office visit. It prevents pregnancy for up to 3 years.

Why Miudella’s approval matters

Miudella is the first new copper IUD to be approved in over 40 years, offering a reliable birth control option for those who prefer hormone-free contraception. It has a smaller, flexible design that’s easier and more comfortable to insert than older copper IUDs.

Miudella also contains less than half the copper of other copper IUDs. This can help reduce the risk of menstrual side effects.

13. Journavx

What is it: Journavx is a non-opioid medication for adults that treats acute moderate-to-severe pain.

FDA approval date: January 30, 2025

How it’s used: Journavx is an oral tablet. You should take it twice daily for the shortest amount of time that you need it (up to 14 days).

Why Journavx’s approval matters

If you have moderate-to-severe pain, you may be prescribed an opioid. But opioids also have serious side effects and risks to consider. And until recently, there haven’t been any breakthroughs with non-opioid options for relief.

This changed with Journavx, a first-in-class opioid alternative for pain. It’s the first new medication that works differently for pain in over 20 years. It works by blocking a specific sodium channel so pain signals don’t reach the brain.

Because of how it works, Journavx isn’t expected to cause drowsiness, dependency, or misuse like opioids.

14. Ozempic

What is it: Ozempic is a popular GLP-1 receptor agonist. It’s now approved to reduce kidney and cardiovascular risks in people with Type 2 diabetes and chronic kidney disease (CKD).

FDA approval date: January 28, 2025

How it’s used: Ozempic is a once-weekly injection that comes as an injection pen. You’ll inject a dose once a week under the skin.

Why Ozempic’s approval matters

Originally approved for Type 2 diabetes, Ozempic has a growing list of benefits and uses. Most recently, it has been shown to provide a benefit for people with Type 2 diabetes who also have CKD. This is significant because it’s estimated that 1 out of every 3 adults with diabetes also have CKD.

During clinical trials, people receiving Ozempic had a 24% lower risk of major kidney disease-related events compared to those who didn’t receive it. There was also an 18% lower risk of major cardiovascular events and a 20% lower risk of death from any cause.

Now that Ozempic is approved for people with Type 2 diabetes and CKD, this is another reason Ozempic may be considered over other diabetes treatment options.

Summary of 2024 approvals

Many medications were approved in 2024. These are 23 of the most notable approvals from the year.

Why trust our experts?

Written by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Patricia Pinto-Garcia, MD, MPH

Patricia Pinto-Garcia, MD, MPH, is a medical editor at GoodRx. She is a licensed, board-certified pediatrician with more than a decade of experience in academic medicine.

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