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, age groups, or formulations. 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 an estimate of when the FDA will be able to respond to an 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.

Moderna mRNA flu vaccine

Moderna’s investigational flu vaccine (mFlusiva) could become the first messenger RNA (mRNA) vaccine approved for seasonal influenza. Unlike traditional flu vaccines, it uses the same mRNA technology as Moderna’s COVID-19 vaccine to teach the immune system to recognize flu viruses.

If approved, mFlusiva could expand flu vaccine options for older adults and pave the way for future combination vaccines, such as combination flu and COVID shots. Clinical trials found the vaccine produced strong immune responses against flu virus strains, particularly among older adults.

Seasonal flu vaccines have relied on similar production methods for decades. An mRNA flu vaccine could make it easier to update vaccines as flu viruses evolve and may improve protection for certain populations.

In June, an FDA advisory panel voted unanimously in favor of mFlusiva. An FDA response is expected by August 5, 2026.

Tavapadon for Parkinson’s disease

Tavapadon is an investigational oral medication for Parkinson’s disease (PD). It uses a different approach than many currently available treatments.

Many PD medications either replace dopamine (such as carbidopa / levodopa) or activate multiple dopamine receptors (binding sites). Tavapadon selectively activates dopamine D1 and D5 receptors, which may improve movement symptoms while reducing certain side effects associated with other dopamine-based medications.

If approved, tavapadon would become the first selective D1/D5 receptor agonist available in the U.S., expanding treatment options for PD. It could be used on its own in early PD or alongside levodopa.

The FDA is expected to make a decision during the third quarter of 2026.

Ianalumab

Ianalumab is an investigational injection being studied for Sjögren’s disease, an autoimmune condition that attacks the glands responsible for making tears and saliva.

There are currently no FDA-approved medications for Sjögren’s disease that address the underlying condition. Instead, most available treatments focus on managing symptoms, such as dry eyes and dry mouth.

If approved, ianalumab could become the first FDA-approved treatment that targets the underlying immune process of Sjögren’s disease. This medication is a lab-made antibody that’s designed to deplete B cells and interfere with their activation and survival, which may reduce symptoms and disease activity.

The FDA could make a decision as early as the second half of 2026.

Cosentyx for PMR

Cosentyx is a biologic medication that’s already approved for several inflammatory conditions, including psoriasis and psoriatic arthritis. The manufacturer is now seeking approval for polymyalgia rheumatica (PMR), an inflammatory condition that causes widespread muscle pain and stiffness.

PMR is usually treated with corticosteroids. But long-term steroid use can lead to serious side effects, such as osteoporosis, heart disease, and infections. Kevzara (sarilumab) is currently the only FDA-approved biologic for PMR. It’s usually reserved for people who don’t respond well to steroids or need to reduce their steroid dose.

If approved, Cosentyx would become the second biologic approved for PMR and the first to target interleukin-17A, a protein involved in inflammation. In clinical trials, more people receiving Cosentyx achieved sustained remission while reducing their steroid use compared with those receiving a placebo (injection without medication).

The FDA could issue a response as early as the second half of 2026.

Insulin efsitora alfa

Most long-acting (basal) insulins, such as Lantus (insulin glargine), are injected every day. In recent years, researchers have developed even longer-acting insulins that only need to be injected once a week.

In March 2026, the FDA approved Awiqli (insulin icodec-abae) as the first once-weekly basal insulin for people with Type 2 diabetes. Later this year, insulin efsitora alfa may become the second weekly basal insulin approved in the U.S.

Clinical trials found that insulin efsitora alfa managed blood glucose (sugar) levels as well as commonly prescribed daily basal insulins. If approved, it would provide another once-weekly insulin option, which may be especially helpful for people who find daily injections difficult to maintain.

An FDA decision could happen during the second half of 2026.

Mounjaro for cardiovascular risk reduction

Mounjaro is a weekly injection currently approved for Type 2 diabetes. It works by mimicking two gut hormones: glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1). In 2026, Mounjaro could join the growing group of diabetes medications that can also reduce the risk of serious cardiovascular problems.

Clinical trials found that Mounjaro lowered the risk of heart attack, stroke, or cardiovascular death for adults with Type 2 diabetes and heart disease. If approved, it would become the first medication in its class approved to reduce cardiovascular risk.

The FDA could issue a response during the second half of 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 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 received 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.

Ozempic pill 25 mg dose

Earlier in 2026, Ozempic’s manufacturer launched a new formulation of oral semaglutide under the Ozempic brand name. This new Ozempic pill will replace Rybelsus, the original formulation. Ozempic is now available in two forms: a daily pill and weekly injection.

Currently, there are three Ozempic pill doses available: 1.5 mg, 4 mg, and 9 mg. The manufacturer is seeking approval for a 25 mg dose, providing higher-dose options for people who prefer pills over injections.

The FDA is expected to issue a response by the end of 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:

Christina Aungst, PharmD, MWC

Christina Aungst, PharmD, MWC is a senior pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019.

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