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Original New Drug Application Approvals by US FDA (16-31 January 2026)

New drug applications approved by US FDA as of 16-31 January 2026 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16-31 January 2026)

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Sublingual cyclobenzaprine fares well in fibromyalgia trial

27 Jan 2026 by

Taking sublingual cyclobenzaprine (TNX-102 SL) at bedtime relieves fibromyalgia symptoms and improves function, a phase III study suggests.

Sublingual cyclobenzaprine fares well in fibromyalgia trial

27 Jan 2026

Heart failure risk high in patients with systemic autoimmune inflammatory diseases

25 Jan 2026

Patients with systemic autoimmune inflammatory diseases—including systemic sclerosis, systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA)—face an increased risk of heart failure (HF), as suggested in a retrospective study.

Heart failure risk high in patients with systemic autoimmune inflammatory diseases

25 Jan 2026

JSpADA passes disease measure validation for enthesitis-related, juvenile PsA

21 Jan 2026 by

A post hoc analysis of the JUNIPERA study has validated the Juvenile Spondyloarthritis Disease Activity Index (JSpADA) as a disease measure for children with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (jPsA) in a prospective clinical trial setting, discriminating between active and inactive disease.

JSpADA passes disease measure validation for enthesitis-related, juvenile PsA

21 Jan 2026

Vasculitis care marred by diagnostic delays, limited access to medications

15 Jan 2026

Several factors, such as diagnostic delays and limited access to medications, pose as barriers to vasculitis care, according to a study.

Vasculitis care marred by diagnostic delays, limited access to medications

15 Jan 2026

Patients with JIA suffer poorer HRQOL than RA, general populations

14 Jan 2026

Health-related quality of life (HRQOL) is lower in patients with juvenile idiopathic arthritis (JIA) than those with rheumatoid arthritis (RA) and the general population 6 months following the initiation of disease-modifying antirheumatic drug (DMARD) treatment, reveals a study. Both patient groups, however, enjoy similar improvement levels with treatment.

Patients with JIA suffer poorer HRQOL than RA, general populations

14 Jan 2026

Fertility factors linked to osteoporosis risk

13 Jan 2026

Women with a history of infertility, miscarriage or stillbirth, and low parity are at increased risk of osteoporosis, as suggested in a study.

Fertility factors linked to osteoporosis risk

13 Jan 2026

Subcutaneous anifrolumab beneficial in systemic lupus erythematosus

10 Jan 2026

Administering anifrolumab shots in addition to standard therapy is safe and yields clinically meaningful benefits in moderate to severe systemic lupus erythematosus, according to the phase III TULIP-SC trial.

Subcutaneous anifrolumab beneficial in systemic lupus erythematosus

10 Jan 2026

Lemon water found to have urate-lowering effect

09 Jan 2026 by

Drinking lemon water regularly can be beneficial to people with gout and hyperuricemia, helping reduce serum urate levels and improve glomerular filtration rate, according to new research.

Lemon water found to have urate-lowering effect

09 Jan 2026

Pharmacist-led education improves caregiver’s JIA knowledge

01 Jan 2026 by

Counselling provided by a pharmacist enhances the caregiver’s knowledge about juvenile idiopathic arthritis (JIA) and may even reduce costs for patients with JIA, according to a Singapore study.

Pharmacist-led education improves caregiver’s JIA knowledge

01 Jan 2026

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Original New Drug Application Approvals by US FDA (16-31 January 2026)

Original New Drug Application Approvals by US FDA (16-31 January 2026)

Sublingual cyclobenzaprine fares well in fibromyalgia trial

Sublingual cyclobenzaprine fares well in fibromyalgia trial

Heart failure risk high in patients with systemic autoimmune inflammatory diseases

Heart failure risk high in patients with systemic autoimmune inflammatory diseases

JSpADA passes disease measure validation for enthesitis-related, juvenile PsA

JSpADA passes disease measure validation for enthesitis-related, juvenile PsA

Vasculitis care marred by diagnostic delays, limited access to medications

Vasculitis care marred by diagnostic delays, limited access to medications

Patients with JIA suffer poorer HRQOL than RA, general populations

Patients with JIA suffer poorer HRQOL than RA, general populations

Fertility factors linked to osteoporosis risk

Fertility factors linked to osteoporosis risk

Subcutaneous anifrolumab beneficial in systemic lupus erythematosus

Subcutaneous anifrolumab beneficial in systemic lupus erythematosus

Lemon water found to have urate-lowering effect

Lemon water found to have urate-lowering effect

Pharmacist-led education improves caregiver’s JIA knowledge

Pharmacist-led education improves caregiver’s JIA knowledge