Novel FDA drug approvals Q1-Q2 2026: the fifteen drugs and their formulary implications

Through May 26, 2026, the FDA has approved 15 novel drugs — new molecular entities and new biological products entering the US market for the first time. Several carry first-in-class mechanisms, and at least five will drive new specialty spend categories that formulary committees had not previously managed.

This mid-year review summarizes each approval, highlights the drugs with the greatest formulary and access impact, and notes what payers, health-system pharmacists, and market-access teams should be watching.

All 15 novel approvals January through May 2026

Sources: FDA Novel Drug Approvals for 2026 page; Drugs.com New Drug Approvals.

Five approvals with the highest formulary impact

Foundayo (orforglipron) — first oral small-molecule GLP-1 for obesity

Eli Lilly's Foundayo is the first non-peptide GLP-1 receptor agonist approved for chronic weight management. It was also the first new molecular entity approved under the FDA's Commissioner's National Priority Voucher (CNPV) pilot program, receiving approval just 50 days after filing — the fastest NME approval since 2002.

In the phase 3 ATTAIN-1 trial, adults on the highest dose (17.2 mg) lost an average of 27 pounds at 72 weeks. Unlike oral semaglutide (Rybelsus, Wegovy pill), Foundayo has no food or water restrictions.

Formulary positioning. Lilly launched Foundayo through LillyDirect with self-pay pricing from $149/month for the lowest dose to $349/month for the highest dose. Commercially insured patients with the savings card may pay as little as $25/month. Eligible Medicare Part D patients may access it for $50/month starting July 2026. The pricing undercuts injectable GLP-1s significantly and could shift payer behavior if outcomes data holds.

What to watch. Payers must decide how to tier an oral GLP-1 against injectable semaglutide and tirzepatide. Step-edits requiring a trial of oral therapy before injectables are likely. CVS Caremark's July 2026 formulary updates may provide an early signal.

Veppanu (vepdegestrant) — first PROTAC degrader

Arvinas and Pfizer's Veppanu is the first FDA-approved PROteolysis TArgeting Chimera (PROTAC), a heterobifunctional protein degrader that eliminates — rather than inhibits — the estrogen receptor. It was approved for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy.

The approval was based on the phase 3 VERITAC-2 trial, where vepdegestrant reduced the risk of disease progression or death by 43% versus fulvestrant in ESR1-mutated patients (HR 0.57). The FDA also approved Guardant360 CDx as a companion diagnostic.

NCCN added vepdegestrant as a Category 2A option within a week of approval. Rigel Pharmaceuticals entered an exclusive global licensing agreement for commercialization on May 12, 2026.

Formulary positioning. As an oral targeted therapy for a biomarker-selected population, Veppanu will likely be managed at the specialty tier with prior authorization requiring ESR1-mutation confirmation via an FDA-authorized test. Pfizer's PfizerForAll program offers patient assistance.

Baxfendy (baxdrostat) — first aldosterone synthase inhibitor

AstraZeneca's Baxfendy is the first-in-class aldosterone synthase inhibitor, approved as add-on therapy for adults with uncontrolled or resistant hypertension. In the phase 3 BaxHTN trial, baxdrostat 2 mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted) on top of standard of care.

AstraZeneca projects peak sales of $5 billion. The drug is expected to be available by early June 2026. A second aldosterone synthase inhibitor, Mineralys Therapeutics' lorundrostat, is behind in development, giving Baxfendy an exclusive window through at least Q3 2026.

Formulary positioning. Baxfendy will compete against generic spironolactone and eplerenone on cost. Payers are likely to require documentation of spironolactone intolerance or contraindication before approving Baxfendy. Expect Tier 3 placement with prior authorization on most commercial formularies initially.

Icotyde (icotrokinra) — first oral IL-23 receptor antagonist

Johnson & Johnson's Icotyde is the first oral peptide that blocks the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in patients aged 12 and older weighing at least 40 kg. Data from the phase 3 ICONIC program (approximately 2,500 patients) showed "biologic-like" efficacy with once-daily oral dosing.

J&J has guided that Icotyde could exceed $5 billion in peak sales. The drug is administered as 200 mg once daily on an empty stomach with a 30-minute fast before eating.

Formulary positioning. Icotyde disrupts the injectable IL-23 market (Skyrizi, Stelara, Tremfya, Omvoh). Prior authorization criteria emerging in early 2026 require diagnosis of moderate-to-severe plaque psoriasis and candidate status for systemic therapy. Given that this is an oral option with biologic-comparable efficacy, payers may prefer it as a step-therapy requirement before injectable IL-23 agents. J&J's ICOTYDE withMe program offers prior authorization support and up to three years of free drug for commercially insured patients if coverage is delayed or denied.

Awiqli (insulin icodec-abae) — once-weekly basal insulin

Novo Nordisk's Awiqli is the first once-weekly basal insulin approved in the US, indicated for glycemic control in adults with type 2 diabetes. The once-weekly injection could simplify the insulin regimen for millions of patients and may compete directly with daily basal insulins (insulin glargine, insulin degludec) that are increasingly available as low-cost biosimilars.

Formulary positioning. Payers will evaluate whether the convenience of once-weekly dosing justifies a premium over generic daily basal insulin. Expect step-edit requirements and prior authorization for most commercial plans. Medicare Part D positioning will depend on how Awiqli is priced relative to biosimilar insulin glargine.

Notable pipeline and policy context

• CNPV pilot. Foundayo's approval in 50 days under the CNPV program is a landmark. The FDA will host a public meeting on June 4, 2026, to discuss eligibility criteria and program implementation. If the program expands, future novel approvals could arrive faster, compressing the time access teams have to prepare.
• Accelerated approvals. Beqalzi (sonrotoclax) received accelerated approval for relapsed/refractory mantle cell lymphoma. Launch teams should monitor confirmatory trial timelines and understand that accelerated status carries ongoing verification risk.
• Companion diagnostics. Veppanu's approval with Guardant360 CDx as a companion diagnostic is the latest example of biomarker-driven access. Prescribers and access teams must ensure ESR1-mutation testing is ordered and documented before initiating prior authorization.

What access teams should do now

1. Monitor formulary placements for Foundayo, Veppanu, Icotyde, and Baxfendy through Q3 2026 P&T cycles. These four drugs are most likely to reshape formularies in obesity, oncology, dermatology, and cardiovascular respectively.
2. Update prior authorization templates for ESR1-mutation testing (Veppanu) and hypertension treatment history (Baxfendy).
3. Track the CNPV program — faster approvals mean less lead time for access teams to prepare coverage criteria.
4. Watch for the oral GLP-1 cascade. Foundayo's launch, combined with the Wegovy pill (approved late 2025, launched January 2026), could drive rapid payer adoption of oral GLP-1s with step-edit requirements before injectable coverage.

Sources

• FDA. Novel Drug Approvals for 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
• Drugs.com. New FDA Drug Approvals for 2026. https://www.drugs.com/newdrugs.html
• Eli Lilly and Company. FDA Approves Lilly's Foundayo (orforglipron). Press release, April 1, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill
• FDA. FDA Approves First New Molecular Entity Under National Priority Voucher Program. Press announcement, April 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program
• Arvinas Inc. Arvinas Announces FDA Approval of VEPPANU (vepdegestrant). Press release, May 1, 2026. https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-fda-approval-veppanu-vepdegestrant-treatment
• FDA. FDA Approves Vepdegestrant for ER-positive, HER2-negative, ESR1-mutated Advanced or Metastatic Breast Cancer. May 1, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
• Rigel Pharmaceuticals. Rigel Enters Exclusive Global Licensing Agreement for VEPPANU. Press release, May 12, 2026. https://www.rigel.com/investors/news-events/press-releases/detail/437
• AstraZeneca. Baxfendy Approved in the US as the First and Only Aldosterone Synthase Inhibitor Treatment for Adults with Hypertension. Press release, May 18, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/Baxdrostat-MNR-2026.html
• Johnson & Johnson. FDA Approval of ICOTYDE (icotrokinra). Press release, March 18, 2026. https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide
• Milliman. 4 Pending FDA Approvals Payers, PBMs, and Market Access Teams Should Be Preparing For Now. 2026. https://www.milliman.com/en/insight/4-pending-fda-approvals-payers-pbms-market-access-teams
• Nature Reviews Drug Discovery. First PROTAC gains FDA approval. May 2026. https://www.nature.com/articles/d41573-026-00078-6