FDA Approval Watch: New Drugs, Doses, and Indications Pending Approval in Late 2026

The year 2026 has already seen some notable medication approvals by the FDA: Xocova, Foundayo, and Lipfendra, to name just a few. The first messenger RNA (mRNA) vaccine for seasonal influenza (mFlusiva) was also recently approved. 

So what else can we expect before the end of 2026? Here’s a look at some possible approvals to watch for in the second half of the year.

Summary of upcoming 2026 FDA approvals

Here’s a summary of several notable FDA approvals that could happen by the end of 2026. In the following sections, we’ll review each one in greater detail.

Tavapadon for Parkinson’s disease

Tavapadon is an investigational oral medication for Parkinson’s disease (PD) that selectively activates D1 and D5 receptors. Phase 3 clinical trial results suggest it improves motor symptoms while reducing 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 as adjunctive treatment in people already taking levodopa.

Ianalumab for Sjögren’s

Ianalumab is a fully human monoclonal antibody medication being studied for Sjögren’s disease. Ianalumab targets BAFF-R, a receptor involved in B-cell activation and survival. By doing so, it blocks B-cell signaling and depletes B cells.

NEPTUNUS-1 and NEPTUNUS-2 are global, multicenter phase 3 studies evaluating the efficacy and safety of ianalumab in people with Sjögren’s. Clinical trial results were presented at the American College of Rheumatology (ACR) Congress in 2025; they’re not yet published.

If approved, ianalumab would become the first FDA-approved treatment that targets the underlying immune process of Sjögren’s disease.

Cosentyx for PMR

Cosentyx is a biologic medication approved for inflammatory conditions such as psoriasis and psoriatic arthritis. The manufacturer is now seeking approval for polymyalgia rheumatica (PMR). Phase 3 results found that more people receiving Cosentyx achieved sustained remission while reducing their steroid use compared with those receiving placebo.

Anti IL-6 Kevzara (sarilumab) is currently the only FDA-approved biologic for PMR. If approved, Cosentyx would become the second biologic approved for PMR and the first to target interleukin-17A.

Insulin efsitora alfa

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.

In clinical trials, insulin efsitora alfa lowered A1C by a similar amount as commonly prescribed daily basal insulins, with a similar hypoglycemia risk.

CagriSema for weight loss

CagriSema is an injectable medication that combines cagrilintide, an amylin analog, with GLP-1 receptor agonist semaglutide. In the REDEFINE 1 trial, participants without diabetes lost an average of about 20% of their body weight after 68 weeks. In the REDEFINE 2 trail, participants with Type 2 diabetes lost 14% in that timeframe. 

In REDEFINE-4, cagrilintide / semaglutide was associated with a 23% weight loss at 84 weeks but was not superior to tirzepatide (25.5%). Safety data are generally similar to that of other GLP-1s.

If approved, it would be the first amylin/GLP-1 combination treatment.

Ozempic pill 25 mg dose

Earlier in 2026, the FDA approved an oral formulation of Ozempic that will replace Rybelsus, the original formulation. Currently, there are 3 Ozempic pill doses available: 1.5 mg, 4 mg, and 9 mg.

Now the manufacturer is seeking approval for a 25 mg dose, with a decision expected by the end of the year.

Why trust our experts?

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.

Edited by:

Mandy Armitage, MD

Mandy Armitage, MD, has combined clinical medicine with her passion for education and content development for many years. She is co-executive director at Nonclinical Physicians Network and has served as medical director for the health technology companies HealthLoop (now Get Well) and Doximity.

Our editorial standards

Meet our experts