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Original New Drug Application Approvals by US FDA (01-15 January 2024)

18 Jan 2024

New drug applications approved by US FDA as of 01-15 January 2024 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 (01-15 January 2024)

18 Jan 2024

Original New Drug Application Approvals by US FDA (16-31 December 2023)

03 Jan 2024

New drug applications approved by US FDA as of 16-31 December 2023 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 December 2023)

03 Jan 2024

Acitretin plus triamcinolone treats oral lichen planus better than triamcinolone monotherapy

21 Dec 2023

The combination of oral acitretin plus topical triamcinolone acetonide (TAC) appears to have superior efficacy than TAC alone in the treatment of patients with oral lichen planus, as shown in a study.

Acitretin plus triamcinolone treats oral lichen planus better than triamcinolone monotherapy

21 Dec 2023

Long-term risankizumab safe, effective in moderate-to-severe plaque psoriasis

20 Dec 2023 by

Treatment with risankizumab in the long term shows lasting efficacy against moderate-to-severe plaque psoriasis and has good tolerability, according to the LIMMitless study.

Long-term risankizumab safe, effective in moderate-to-severe plaque psoriasis

20 Dec 2023

Original New Drug Application Approvals by US FDA (01-15 December 2023)

18 Dec 2023

New drug applications approved by US FDA as of 01-15 December 2023 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 (01-15 December 2023)

18 Dec 2023

Low-dose methotrexate may pose serious adverse event risk for older adults with CKD

05 Dec 2023 by

For older adults with chronic kidney disease (CKD) who are initiating a disease-modifying antirheumatic drug (DMARD), low-dose methotrexate appears to be associated with a heightened 90-day risk of serious adverse events compared with hydroxychloroquine, as shown in a study.

Low-dose methotrexate may pose serious adverse event risk for older adults with CKD

05 Dec 2023

Remibrutinib improves CSU symptoms in phase III trials

05 Dec 2023 by

Treatment with the investigational, oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib improves symptoms in patients with chronic spontaneous urticaria (CSU) inadequately controlled on antihistamines, the phase III REMIX-1 and -2 studies have shown.

Remibrutinib improves CSU symptoms in phase III trials

05 Dec 2023

Givosiran delivers safe, sustained improvements in acute hepatic porphyria

28 Nov 2023 by

Long-term monthly treatment with givosiran has good tolerability and offers continuous improvements to patients with acute hepatic porphyria (AHP), results of the phase III ENVISION trial have shown.

Givosiran delivers safe, sustained improvements in acute hepatic porphyria

28 Nov 2023

Roflumilast improves skin clearance in patients with AD

27 Nov 2023 by

Once-daily treatment with topical roflumilast cream 0.15% demonstrates a significant improvement in vIGA-AD* score, achieving a clear or almost clear status, in patients with mild-to-moderate atopic dermatitis (AD), according to the pooled analysis of the phase III INTEGUMENT-1/2 studies presented at ACAAI 2023.

Roflumilast improves skin clearance in patients with AD

27 Nov 2023

Garadacimab provides early protection against HAE attacks

24 Nov 2023 by

Subcutaneous prophylactic treatment with garadacimab significantly reduced the monthly number of attacks and led to attack-free status as early as week 1 in patients with hereditary angioedema (HAE) in the post hoc analysis of the phase III VANGUARD study presented at ACAAI 2023.

Garadacimab provides early protection against HAE attacks

24 Nov 2023

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Original New Drug Application Approvals by US FDA (01-15 January 2024)

Original New Drug Application Approvals by US FDA (01-15 January 2024)

Original New Drug Application Approvals by US FDA (16-31 December 2023)

Original New Drug Application Approvals by US FDA (16-31 December 2023)

Acitretin plus triamcinolone treats oral lichen planus better than triamcinolone monotherapy

Acitretin plus triamcinolone treats oral lichen planus better than triamcinolone monotherapy

Long-term risankizumab safe, effective in moderate-to-severe plaque psoriasis

Long-term risankizumab safe, effective in moderate-to-severe plaque psoriasis

Original New Drug Application Approvals by US FDA (01-15 December 2023)

Original New Drug Application Approvals by US FDA (01-15 December 2023)

Low-dose methotrexate may pose serious adverse event risk for older adults with CKD

Low-dose methotrexate may pose serious adverse event risk for older adults with CKD

Remibrutinib improves CSU symptoms in phase III trials

Remibrutinib improves CSU symptoms in phase III trials

Givosiran delivers safe, sustained improvements in acute hepatic porphyria

Givosiran delivers safe, sustained improvements in acute hepatic porphyria

Roflumilast improves skin clearance in patients with AD

Roflumilast improves skin clearance in patients with AD

Garadacimab provides early protection against HAE attacks

Garadacimab provides early protection against HAE attacks