FDA and EMA Drug Approvals: February 2026

Updated on March 20,2026|Written by Patsnap Team

The United States and European Union each delivered two drug approvals in February 2026. The FDA approved a first-in-class synthetic peptide for achondroplasia and a new antipsychotic for schizophrenia and bipolar I disorder. The EMA granted marketing authorization to two biosimilars in immunology and ophthalmology.

All data is sourced from Patsnap Synapse, an AI-powered drug intelligence platform with real-time global regulatory coverage.

FDA Approvals — February 2026

1. Navepegritide / Yuviwel (Ascendis Pharma) — Achondroplasia

Approval date: February 27, 2026
Drug type: Synthetic PEGylated peptide (prodrug)
Target: NPRC (natriuretic peptide receptor C)
Indication: Achondroplasia with open epiphyses, in patients aged 2 years and older
Regulatory pathway: FDA Accelerated Approval Program

Navepegritide — branded Yuviwel — is the first once-weekly treatment approved for achondroplasia and the only one to provide continuous systemic exposure to C-type natriuretic peptide (CNP) over the weekly dosing interval. It is a prodrug: following subcutaneous injection, it releases active CNP, which binds NPR-B, stimulates cGMP production, and suppresses MAPK signalling downstream of the mutant FGFR3 receptor — counteracting the overactive FGFR3 signalling that drives impaired endochondral bone growth in achondroplasia.

Achondroplasia affects approximately 1 in 20,000–30,000 live births and is caused by gain-of-function mutations in FGFR3. Most cases are de novo mutations rather than inherited. For an authoritative clinical overview, see the FDA prescribing information for Yuviwel.

Approval rested on three randomized, double-blind, placebo-controlled trials including the pivotal ApproaCH study (NCT05598320), in which navepegritide demonstrated superiority in annualized growth velocity at week 52. According to Pharmacy Times’ clinical summary, mean annualized growth velocity with navepegritide was 5.89 cm/year versus 4.41 cm/year with placebo (P < .001). No patients in the navepegritide arm discontinued due to adverse events.

A Rare Pediatric Disease Priority Review Voucher was issued alongside the approval. The comparison drug vosoritide (Voxzogo) requires daily injections — navepegritide’s once-weekly schedule is a meaningful differentiator for adherence. For the full announcement, see Ascendis Pharma’s press release on GlobeNewswire.

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→ Full drug profile: Navepegritide — targets, patents, clinical data

2. Milsaperidone (Vanda Pharmaceuticals) — Schizophrenia and Bipolar I

Approval date: February 20, 2026
Drug type: Small molecule
Targets: 5-HT2A receptor; D2 receptor
Indications: Schizophrenia; Bipolar I disorder

Milsaperidone is an atypical antipsychotic with dual serotonin–dopamine receptor activity. This receptor profile — D2 antagonism combined with 5-HT2A antagonism — is consistent with the pharmacology of established second-generation antipsychotics (SGAs), which generally produce fewer extrapyramidal side effects than first-generation D2-only agents.

According to the WHO schizophrenia fact sheet, schizophrenia affects approximately 24 million people worldwide, with onset typically in late adolescence or early adulthood. Despite the existing suite of SGAs, a significant treatment gap persists: fewer than one-third of people with psychosis receive specialist mental health care globally.

The D2/5-HT2A antipsychotic class is commercially crowded — including risperidone, olanzapine, quetiapine, and aripiprazole — but differentiation through dosing convenience, metabolic tolerability, or receptor selectivity continues to drive new entrants. Milsaperidone’s specific pharmacological differentiation relative to marketed SGAs will become clearer as post-launch real-world data accumulates.

Want to track the full competitive landscape, patent estate, and clinical pipeline for this target? Search this target on Patsnap Synapse →

EMA Approvals — February 2026

3. Golimumab Biosimilar / Bio-Thera (STADA Arzneimittel) — Immunological conditions

Approval date: February 10, 2026
Drug type: Biosimilar monoclonal antibody
Target: TNF-α
Indications: Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis

This biosimilar to Janssen’s Simponi (golimumab) was developed by Bio-Thera Solutions and commercialised by STADA Arzneimittel. Golimumab is a fully human IgG1κ monoclonal antibody that neutralises both soluble and transmembrane TNF-α, suppressing inflammatory signalling across multiple immune-mediated diseases. Biosimilar entry in this class typically drives 20–40% price reductions, improving patient access in public healthcare systems.

The EU established the world’s first biosimilar regulatory framework in 2006, and the EMA has now approved over 90 biosimilar medicines. For the regulatory foundation governing this approval, see the EMA biosimilar medicines overview. The EMA has also confirmed that approved biosimilars are interchangeable with their reference medicines — see their interchangeability statement.

4. Ranibizumab Biosimilar / Rubi (Lupin Ltd) — Retinal conditions

Approval date: February 10, 2026
Drug type: Fab fragment; biosimilar
Target: VEGF-A
Indications: Wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy, retinal vein occlusion, choroidal neovascularization

Lupin’s Rubi biosimilar references Novartis/Roche’s Lucentis (ranibizumab) — a VEGF-A-targeting Fab fragment administered intravitreally. Anti-VEGF therapies are the standard of care across multiple retinal neovascularisation conditions, and ranibizumab was among the first anti-VEGF agents approved, preceding the wider adoption of aflibercept and newer long-acting agents such as faricimab.

Wet AMD is a leading cause of vision loss in adults over 50. Biosimilar entry in ophthalmology expands prescribing options and may reduce out-of-pocket costs where originator pricing remains high. The EMA biosimilar framework’s interchangeability confirmation is directly relevant for clinical decision-making around switching patients between ranibizumab formulations.

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US & EU: Notable ERP Designations in February 2026

Several US- and EU-originated drugs advanced through expedited channels in February:

Biosimilar Momentum in Europe

Both EMA approvals in February were biosimilars. With over 90 approved since 2006, the EU’s biosimilar programme is the most mature in the world. The February additions reinforce coverage of key biologic targets — TNF-α and VEGF-A join previously approved biosimilars for adalimumab, infliximab, trastuzumab, and bevacizumab.

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Further Reading

• Global drug approvals roundup — February 2026
• APAC drug approvals — China and South Korea, February 2026
• Japan iPSC cell therapy approvals — February 2026
• Navepegritide: NPRC target profile and drug profile
• What are FDA Accelerated Approval and Breakthrough Therapy designations?

Data sourced from Patsnap Synapse. Regulatory classifications reflect filings as of February 2026. This post is for informational purposes only.