FDA Approval Watch: New Drugs, Vaccines, and Therapies Pending Approval in 2025

Over the course of 2024, the FDA approved several notable new drugs and vaccines — from the first obstructive sleep apnea medication to the first biologic for chronic obstructive pulmonary disease (COPD). And looking into 2025, there are several other innovative “firsts” on the way.

Some anticipated FDA approvals involve new medications that aren’t currently on the market. The FDA might also choose to expand an existing medication’s use, approving it for new health conditions or age groups. Below, we cover potential FDA approvals to watch for in 2025.

Summary of upcoming 2025 FDA approvals

After the FDA accepts an application for a new drug, biologic, or use, a PDUFA (Prescription Drug User Fee Act) date is usually issued. The PDUFA date is when the FDA is expected to respond to the application. Sometimes, the FDA might have an advisory committee meet to issue a recommendation first before making its decision. The FDA usually goes along with the committee’s recommendation — but not always.

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• Latest news: Significant advancements are being made in medicine every day. Learn more about notable new drugs, vaccines, and other treatments that have been recently approved.

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• Seal of approval: The FDA is a government agency that’s tasked with protecting public health. But you may be surprised to learn what the FDA’s responsibilities actually include.

In the table below, we summarize the PDUFA and advisory committee dates for several notable FDA approvals that could happen in 2025. In the following sections, we’ll review each one in greater detail.

Gepotidacin for UTIs

Urinary tract infections (UTIs) are common in women, with about 50% experiencing at least one over the course of their lifetime. Most UTIs are uncomplicated — affecting otherwise healthy people with normal urinary tracts.

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, it has been decades since a new oral antibiotic class has been approved for uncomplicated UTIs. This could change in early 2025.

Gepotidacin is a first-in-class oral antibiotic. It has been shown to work against most UTI-causing bacteria, including those that are resistant to current antibiotics. One clinical trial found that gepotidacin worked just as well as nitrofurantoin (Macrobid, Macrodantin), a first-choice antibiotic for UTIs. And another trial found it to be more effective.

Gepotidacin’s manufacturer is seeking approval for the treatment of uncomplicated UTIs in female adults and adolescents age 12 and older. The FDA is expected to issue a response by March 26, 2025.

Cardamyst for PSVT

Paroxysmal supraventricular tachycardia (PSVT) is a type of abnormal heart rhythm that involves sudden episodes of fast heartbeats. The episodes are unpredictable, coming on quickly and lasting minutes to several hours. Oftentimes, people need to go to the ER for treatment. But with Cardamyst (etripamil), people may be able to manage PSVT episodes themselves at home.

Cardamyst is a fast-acting calcium channel blocker that’s administered as a nasal spray. During clinical studies, the medication (given as single or repeat doses) was able to significantly restore normal heart rhythm within 30 minutes. If approved, Cardamyst could help reduce trips to the ER and improve the quality of life for people with PSVT.

An FDA response on Cardamyst for PSVT is expected by March 27, 2025.

Reproxalap for dry eye disease

Dry eye disease is a common health condition that causes eye irritation, redness, and discomfort. Existing treatments help manage symptoms, but many people continue to experience flare-ups and inadequate relief. Reproxalap is a new medication that could offer a new approach to treatment.

Reproxalap is a first-in-class RASP (reactive aldehyde species) modulator. It’s designed to reduce eye inflammation, a key factor in dry eye disease. 

Unlike traditional treatments that primarily focus on lubricating the eyes, reproxalap targets the underlying inflammation contributing to symptoms. It may also work faster than dry eye medications like Restasis (cyclosporine), which can take about 6 months for significant relief. During clinical trials, improvements with reproxalap were seen as early as 2 weeks.

The FDA is expected to make a decision on reproxalap by April 2, 2025.

Dupixent for chronic spontaneous urticaria

Chronic spontaneous urticaria (CSU) is a skin condition that causes recurring hives, swelling, and itching for 6 weeks or longer without a known trigger. Antihistamines are usually tried first. But people may struggle to find relief when antihistamines fail to manage symptoms. Xolair (omalizumab) is currently the only FDA-approved biologic for CSU. But Dupixent (dupilumab), also a biologic, could provide another targeted treatment option this year.

Dupixent is already approved for several inflammatory conditions, including eczema. It works by targeting two key drivers of type 2 inflammation, which is believed to play a role in CSU. During clinical trials, Dupixent significantly reduced itch and hives severity in people with CSU who hadn’t responded to antihistamines.

The manufacturer has requested approval for Dupixent to treat CSU in adults and adolescents age 12 and older. An FDA response is expected by April 18, 2025.

Nucala for COPD

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. If approved, Nucala (mepolizumab) could offer a new treatment option for this specific type of COPD.

Nucala, a biologic medication, is already FDA approved to treat severe eosinophilic asthma and other eosinophil-related health conditions. But its manufacturer is seeking approval to expand its use to COPD with elevated eosinophil levels. In clinical studies, Nucala has been shown to significantly reduce moderate or severe COPD flare-ups in this group.

An FDA decision on Nucala for COPD is expected by May 7, 2025. If approved, it would be the second biologic for this type of COPD and the first available as a once-monthly option.

Novavax COVID vaccine

In July 2022, the FDA first authorized the Novavax COVID-19 vaccine. This allowed the vaccine to be used during the public health emergency without being fully FDA approved. And while updated versions of the Novavax COVID vaccine have been authorized since then, the manufacturer is seeking full approval.

The FDA is expected to issue a response on the Novavax COVID vaccine by April 2025.

Clesrovimab for RSV

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

Like Beyfortus, clesrovimab is a monoclonal antibody — a lab-made antibody designed to bind to RSV and prevent it from entering and infecting cells. But the dosage doesn’t differ based on body weight, which is different from Beyfortus. 

During clinical trials, clesrovimab was shown to lower the risk of RSV disease that required medical care and hospitalization from RSV in infants. If approved, it would be an additional tool for RSV prevention in this vulnerable population. An FDA response is expected by June 10, 2025.

Sebetralstat for hereditary angioedema

Hereditary angioedema (HAE) is a rare, but potentially life-threatening genetic health condition. It involves recurrent episodes of severe swelling that can affect the face, airway, and other areas of the body.

Medications are available to prevent and treat HAE attacks. Treating an attack as soon as possible can help prevent it from getting worse. But when an attack happens, existing treatment options are limited to infusions or injections, which can be burdensome. It may also take longer to start treatment.

Sebetralstat is an oral medication that has shown promising results for treating HAE attacks in people age 12 and older. If approved, it could give people with HAE a more convenient option that allows them to start treatment sooner. The FDA is expected to issue a response on sebetralstat by June 17, 2025.

Elinzanetant

Vasomotor symptoms (VMS) of menopause, such as hot flashes and night sweats, can significantly impact quality of life. Menopausal hormone therapy is a common treatment, but it may not be right for everyone. Non-hormonal options like Veozah (fezolinetant) have recently emerged. And another medication called elinzanetant may soon offer an additional alternative.

Like Veozah, elinzanetant is a non-hormonal medication that targets neurokinin (NK) receptors that help regulate body temperature. But Veozah blocks one NK pathway, while elinzanetant blocks two pathways. Some evidence suggests that it may have a greater effect on VMS compared to fezolinetant. It may also provide improvements in sleep quality.

It has been reported that the FDA is expected to issue a response by July 26, 2025. If approved, it would provide another non-hormonal treatment option for VMS of menopause.

Donidalorsen for preventing HAE attacks

Donidalorsen is another medication that could be approved for HAE. But instead of treating HAE attacks when they happen, donidalorsen would help stop them before they start.

Donidalorsen is a first-in-class RNA-targeted therapy that’s given as a subcutaneous injection. It works by lowering the levels of a protein called prekallikrein that’s involved in a pathway that triggers HAE attacks. Other preventative HAE medications work differently — by replacing deficient proteins or blocking a protein called plasma kallikrein. During clinical trials, people switching from other HAE medications to donidalorsen had a 62% further reduction in average monthly HAE attack rates.

The FDA is expected to provide a response on donidalorsen by August 21, 2025.

Leqembi for Alzheimer’s disease

In June 2023, Leqembi (lecanemab) became the first fully FDA-approved medication of its kind of Alzheimer’s disease. It’s thought to work by targeting beta-amyloid plaques to slow the progression of the disease. Fast forward to January 2025, and the FDA approved a once-monthly maintenance dosage of Leqembi. This gave people receiving Leqembi every 2 weeks the option for less frequent infusions.

For even greater convenience, the manufacturer has now requested the approval of a subcutaneous (under-the-skin) injection pen version of Leqembi. Instead of traveling to a medical office for infusions, you (or a caregiver) could inject Leqembi at home once a week.

The FDA is expected to provide a response on subcutaneous Leqembi by August 31, 2025.

Bumetanide nasal spray

Edema (fluid buildup) is a common complication of congestive heart failure (CHF), liver disease, and kidney disease. Traditional diuretics can help remove excess fluid. But they often require oral or intravenous (IV) administration. This can delay relief in acute situations due to the time required for administration and absorption. A new treatment, bumetanide nasal spray, could offer a fast, non-invasive option that could even be administered at home.

Bumetanide nasal spray is designed to provide rapid diuretic effects by delivering the medication through the nasal passages. This allows it to enter the bloodstream more quickly than standard oral diuretics (water pills). During clinical trials, bumetanide nasal spray worked just as well as IV bumetanide, which is typically used when oral diuretics fail. It was also absorbed at a more reliable rate compared to oral bumetanide.

The FDA is expected to make a decision on bumetanide nasal spray by September 14, 2025. If approved, it would be the first diuretic nasal spray. Experts believe that it could improve at-home management of edema and potentially reduce the need for hospitalizations.

Other potential approvals

Several other notable approvals could happen in 2025. Here are a few to watch for:

• Tirzepatide (Zepbound) for heart failure with preserved ejection fraction (HFpEF)

• Lerodalcibep for high cholesterol

• Oral semaglutide (Rybelsus) to lower the risk of major adverse cardiovascular events (heart attack, stroke, or cardiovascular death)

• Finerenone (Kerendia) for HFpEF

• Lenacapavir (Sunlenca) for HIV pre-exposure prophylaxis (PrEP)

• Nipocalimab for myasthenia gravis

• NP001 for amyotrophic lateral sclerosis (ALS)

• Moderna’s combination COVID and flu vaccine

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Written 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:

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.

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