The approval of the new citrate-free, high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study.
Dermatological Disorders
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About 31% of patients with recalcitrant alopecia areata totalis or universalis had complete hair regrowth.
Results showed a significantly greater proportion of patients treated with tapinarof cream achieved vIGA-AD success compared with vehicle cream.
Furthermore, from 2016 to 2018, tap water scald burns cost $206.7 million in direct health care costs
The sBLA is supported by data from Studies A and B of phase 3 LIBERTY-CUPID trial which included patients with CSU who were inadequately controlled on standard-of-care H1 antihistamines.
The application is supported by data from the pivotal phase 3 B-SIMPLE4 study which included 891 patients 6 months of age and older with molluscum contagiosum.
Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor.
The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study.
However, more frequent headache, dizziness, constipation, increased urine output seen for patients receiving difelikefalin versus placebo
Belimumab is a B-lymphocyte stimulator-specific inhibitor.
Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.
18.9 percent of children and 25.7 percent of adults had seasonal allergy; 10.8 and 7.3 percent had eczema in 2021
The guidelines were developed by a multidisciplinary workgroup.
NexoBrid is a topically administered, bromelain-based biological product containing a sterile mixture of proteolytic enzymes.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F.
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
Lasting improvement seen for patients receiving anti-OX40 antibody rocatinlimab compared with placebo
Among systemic treatments for plaque psoriasis, brodalumab, guselkumab, ixekizumab, and risankizumab-rzaa were found to be associated with the highest Psoriasis Area and Severity Index (PASI) response rates.
Dupixent, an interleukin-4 receptor alpha antagonist, is currently approved for moderate to severe atopic dermatitis in patients ≥12 years old who are not adequately controlled with topical prescription therapies or when they are not advisable.
A recent report published in the New England Journal of Medicine describes the case of a patient with persistent skin discoloration associated with the use of the antiarrhythmic agent amiodarone. The 81-year-old man presented to the emergency department after a fall, which was eventually attributed to orthostatic hypotension. His medical history included atrial fibrillation and…