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

During the first half of 2025, the FDA approved several notable new drugs and vaccines — from a new opioid alternative for pain to the first new oral antibiotic class for uncomplicated urinary tract infections in decades. And looking ahead to the rest of 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 the second half of 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.

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

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.

The FDA issued a response letter on March 28, 2025, requiring additional information related to the manufacturing of Cardamyst. The manufacturer submitted a response to the FDA on June 16, 2025, with a new decision date of December 13, 2025. 

Elinzanetant for hot flashes

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.

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An FDA decision was originally expected by July 26, 2025. But this date has been delayed until October 26, 2025.

Subcutaneous Leqembi for Alzheimer’s disease

In July 2023, Leqembi (lecanemab) became the first fully FDA-approved medication of its kind for 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’re often taken by mouth or infused into a vein. 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.

Subcutaneous Keytruda for various cancers

Keytruda (pembrolizumab) is a widely used immunotherapy medication that treats over 20 different cancers. Today, it’s given as a 30-minute IV infusion in a medical setting. But Keytruda’s manufacturer is hoping to make treatment quicker and more convenient — as a subcutaneous injection that’s given in just minutes.

If approved, the subcutaneous version would be available for all of Keytruda’s current solid tumor uses. The approval wouldn’t cover its indications for lymphoma. The FDA is expected to make a decision by September 23, 2025.

Wegovy injections for HFpEF

Wegovy (semaglutide) is a once-weekly injectable glucagon-like peptide-1 (GLP-1) receptor agonist for weight loss, heart protection, and metabolic dysfunction-associated steatohepatitis (MASH). Along with a growing list of other potential benefits, studies have shown that it may also help certain people with heart failure.

Wegovy could be approved to treat adults living with HFpEF and are considered to be obese. This potential approval is significant because most people with HFpEF have a larger body size — a key driver of disease progression and reduced quality of life. The approval application is backed by data from the STEP-HFpEF trial, which showed that Wegovy helped improve symptoms and physical function in this population.

After initially withdrawing its application in 2024 to provide additional data, the company resubmitted the application in January 2025 with data from the FLOW and SOUL trials. The FDA’s response is anticipated in the second half of 2025. If approved, Wegovy would be the first GLP-1 approved for HFpEF.

Oral Wegovy for weight loss and heart protection

With growing interest with oral GLP-1 weight-loss medications, you may be wondering if there will ever be a Wegovy pill. It could happen sooner than you think.

Wegovy’s manufacturer is seeking approval for a daily oral version of Wegovy — both for weight loss and to reduce the risk of serious cardiovascular problems. During clinical trials, the 25 mg oral semaglutide dose resulted in weight loss similar to the highest Wegovy injection dose (2.4 mg).

If approved, oral Wegovy would offer a needle-free alternative to the weekly injection. The FDA is expected to respond in 4Q 2025.

Other potential approvals

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

• Lerodalcibep for high cholesterol

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

• ONS-5010 (bevacizumab-vikg) for wet age-related macular degeneration

• Ensitrelvir for COVID post-exposure prophylaxis

• Depemokimab for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps

• Blujepa (gepotidacin) for uncomplicated urogenital gonorrhea

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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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