News & Updates

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.

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.

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.

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.

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.

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.

Acupuncture appears more effective than sham acupuncture or waitlist control in patients with chronic spontaneous urticaria (CSU), but the difference from control does not reach statistical significance, reports a study. Adverse events (AEs) associated with acupuncture are either mild or transient.