FDA Approval Watch: New Drugs, Vaccines, and Therapies Pending Approval in 2026

During 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 2026, 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 may also choose to expand certain existing medications’ uses, approving them for new health conditions or age groups. Below, we cover potential FDA approvals to watch for in 2026.

Summary of upcoming 2026 FDA approvals

After the FDA accepts an application for a new drug, new biologic, or existing treatment seeking a new use, a Prescription Drug User Fee Act (PDUFA) date is usually issued. The PDUFA date is when the FDA estimates it will be able to respond to the application. Sometimes, the FDA has an advisory committee meet to issue a recommendation 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 2026. In the following sections, we’ll review each one in greater detail.

Ozempic for peripheral artery disease

Peripheral artery disease (PAD) is a common health condition in which narrowed arteries reduce blood flow, commonly to the legs. This can often cause pain, cramping, and difficulty walking. PAD is especially common in people with Type 2 diabetes. It’s also linked to a higher risk of heart attack, stroke, and cardiovascular death. Currently, treatment options that improve symptoms and function are limited. 

Ozempic (semaglutide), a popular injection for Type 2 diabetes, may offer a new treatment approach. During clinical trials, adults with Type 2 diabetes and PAD who received Ozempic were able to walk farther and reported better quality of life than those who didn’t receive it.

If its application goes forward, Ozempic would be the first medication of its kind approved for PAD. An FDA decision was previously expected in late 2025, but it could still happen in early 2026.

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.

In 2026, Wegovy injections could be approved to treat adults living with heart failure with preserved ejection fraction (HFpEF) who 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.

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After initially withdrawing the application in 2024 to provide additional data, the manufacturer resubmitted it in January 2025 with information from the FLOW and SOUL trials. An FDA response was anticipated in the second half of 2025, but is now expected for sometime in 2026. If the agency signs off, Wegovy would be the first GLP-1 approved for HFpEF.

Anaphylm

Many people who experience severe allergic reactions rely on epinephrine to treat anaphylaxis. Epinephrine autoinjectors like EpiPen are effective. But they can malfunction, expire unnoticed, or feel intimidating for people who aren’t comfortable with needles. Because of this, researchers have been exploring needle-free alternatives.

Neffy, the first epinephrine nasal spray, was approved in 2024. Another option, Anaphylm, is now under FDA review. Anaphylm is a sublingual (under the tongue) film that dissolves and delivers epinephrine through the oral tissues. If approved, it could offer a portable, device-free, and needle-free alternative for people who need emergency epinephrine for severe allergic reactions.

An FDA decision on Anaphylm is expected by January 31, 2026.

Dupixent for allergic fungal rhinosinusitis

Dupixent (dupilumab) is an injectable medication that’s used to treat a growing list of inflammatory health conditions. It’s now pending approval for allergic fungal rhinosinusitis (AFRS), a chronic sinus condition marked by inflammation, nasal obstruction, and recurring infections triggered by fungal allergens. AFRS is primarily driven by type 2 inflammation.

People with AFRS often undergo repeated surgeries and steroid treatments. Dupixent targets and blocks key drivers of type 2 inflammation, which may help improve sinus inflammation, decrease nasal congestion and polyp size, and reduce the need for additional steroids or surgery.

Dupixent would be the first medication approved specifically for AFRS. An FDA decision is expected by February 28, 2026.

Sotyktu for psoriatic arthritis

Sotyktu (deucravacitinib) is an oral tyrosine kinase 2 inhibitor currently approved for plaque psoriasis. Because plaque psoriasis and psoriatic arthritis (PsA) share overlapping inflammatory pathways, researchers have studied whether Sotyktu could also treat PsA.

During clinical trials, people with PsA taking Sotyktu had improvements in their joint symptoms, skin symptoms, and quality of life. If approved for PsA, Sotyktu would offer a once-daily, noninjectable alternative to biologics such as Humira (adalimumab) and Skyrizi (risankizumab-rzaa).

An FDA decision on Sotyktu for PsA is expected by March 6, 2026.

Orforglipron for weight loss

Orforglipron is an investigational, once-daily oral GLP-1 medication being studied for Type 2 diabetes and weight loss. Unlike oral semaglutide (Rybelsus, Wegovy pill), orforglipron can be taken with or without food and doesn’t require specific timing. This may make it easier for people to incorporate it into their daily routine.

During clinical trials, people taking the highest orforglipron dose lost about 11% of their starting body weight, on average, after 72 weeks (almost 17 months). In a separate study, orforglipron helped people maintain the weight they lost from Wegovy and Zepbound (tirzepatide), two injectable GLP-1 weight-loss medications.

The FDA has awarded orforglipron a Commissioner's National Priority Voucher (CNPV), which speeds up the review timeline to 1 to 2 months. It has been reported that an FDA decision could happen in March 2026.

Higher-dose Wegovy for weight loss

As mentioned, Wegovy is an injectable weight-loss medication. Current Wegovy doses range from 0.25 mg to 2.4 mg, which are taken once weekly. But some people don’t achieve their desired weight-loss results with the highest approved dose.

During a clinical trial looking at a higher, 7.2 mg Wegovy dose, people in the higher-dose group lost almost 19% of their starting body weight after 72 weeks. Those who stayed on this dose for the entire study duration lost nearly 21% of their body weight. This is compared to an average of about 15% weight loss with the 2.4 mg dose.

Similar to orforglipron, the 7.2 mg Wegovy dose will be reviewed under the FDA’s CNPV program. An FDA decision is expected in early 2026.

Afrezza for children with diabetes

When you think of insulin, injections likely come to mind. But there’s also an inhaled insulin called Afrezza that’s currently approved for adults with Type 1 or Type 2 diabetes. The manufacturer is now seeking approval for Afreeza’s use in children ages 4 and older, which would make it the first needle-free insulin option for this age group.

Afrezza is an ultra-rapid-acting insulin. It works faster and leaves the body quicker than traditional rapid-acting injected insulins. Studies in children suggest that Afrezza can effectively replace rapid-acting mealtime insulins, reducing the number of daily injections.

An FDA decision on Afrezza’s use in kids is expected by May 29, 2026.

Cytisinicline for smoking cessation

Quitting smoking is difficult, but there are treatment options available to help make the process easier. One non-nicotine option is varenicline (Chantix), which partially activates nicotine receptors (binding sites) in the brain. While effective, varenicline can cause bothersome side effects — from nausea to abnormal dreams.

Cytisinicline (or cytisine), which is currently under FDA review, works in a similar way. Studies suggest that it may work as well as varenicline but with fewer side effects.

Cytisinicline would be the first new FDA-approved smoking cessation medication in about 20 years. An FDA decision is expected by June 20, 2026.

Baxdrostat for high blood pressure

For some people, hypertension (high blood pressure) is difficult to manage even with multiple medications. This condition, often called treatment-resistant hypertension, is associated with an increased risk of serious health problems such as heart attack and stroke.

Baxdrostat is an investigational medication that’s the first in a new class designed to help lower blood pressure in people who haven’t responded well to standard treatments. It works by reducing the production of aldosterone, a hormone that can cause the body to retain salt and water, which can raise blood pressure.

The FDA has granted priority review to baxdrostat, shortening the review time from about 10 months to 6 months. An FDA decision is expected in the second quarter of 2026.

Icotrokinra for plaque psoriasis

Icotrokinra is an investigational oral medication being studied for moderate-to-severe plaque psoriasis. It targets the IL-23 pathway, which plays a key role in psoriasis-related inflammation. Other medications that work this way are currently given as injections.

During clinical trials, over half of the people taking icotrokinra had clear or almost clear skin at 16 weeks (almost 4 months). In a separate trial, icotrokinra was shown to be more effective than Sotyktu, another oral medication that works in a different way for plaque psoriasis. A study comparing icotrokinra to Stelara (ustekinumab), an injectable medication that targets IL-23 (and IL-12), is ongoing.

If approved, icotrokinra would be the first oral IL-23 blocker. An FDA decision could happen in 2026.

CagriSema for weight loss

CagriSema is a combination injectable medication that includes cagrilintide, an amylin analog, and semaglutide, a GLP-1 receptor agonist. Together, these medications work in synergy to reduce appetite and promote weight loss.

Cagrilintide mimics amylin, a hormone that signals fullness to the brain and slows stomach emptying. By targeting multiple appetite-regulating pathways, CagriSema may lead to greater weight loss than GLP-1 therapy alone. In clinical trials, people who took CagriSema for the full length of a study lost an average of 23% of their starting body weight by 68 weeks (nearly 16 months).

An FDA decision on CagriSema’s approval is expected in 2026.

Awiqli for Type 2 diabetes

In fall 2025, Novo Nordisk resubmitted an application to the FDA for Awiqli, a once-weekly basal insulin for adults with Type 2 diabetes. If approved, it would mark the first insulin of its kind available in the U.S. This would be a big shift from the standard daily basal insulin shots that many people living with Type 2 diabetes rely on.

Standard basal insulins are daily long-acting insulins that help keep blood sugar levels stable over the course of 24 hours. Awiqli’s chemical structure helps it last longer in the body, supporting a full week of basal insulin coverage with a single injection. For someone who has been using daily basal insulin, this could reduce their number of injections from 365 to 52 per year.

An FDA response on Awiqli is expected in 2026.

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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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