The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for tapinarof cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. Tapinarof is an aryl hydrocarbon receptor agonist currently marketed under the brand name Vtama® for the topical treatment of…
Dermatological Disorders
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Compared with dupilumab, a significantly higher proportion of patients treated with upadacitinib achieved both EASI 90 and a Worst Pruritus Numerical Rating Scale of 0 or 1.
Prademagene zamikeracel is an autologous cell therapy that consists of epidermal sheets that deliver functional COL7A1 genes into the patient’s own skin cells to enable normal type VII collagen expression and facilitate wound healing.
The Company is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life.
Reduction seen in mean number of days with moderate-to-extreme flushing, moderate-to-severe erythema.
Selarsdi is supplied as 45mg/0.5mL and 90mg/mL single-dose prefilled syringes.
All of the affected individuals were females who received the injections in non-health care settings by untrained individuals who purchased the product from unlicensed sources.
PowerHeal is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, and blisters and is available in a variety of sizes.
The table below is a review of notable updates that occurred in March 2024 for investigational products in development.
Five themes affect long-term prescribing, including perceived lack of evidence to justify change, discomfort discussing contraception
The sBLA is supported by data from the phase 3 BE HEARD I and BE HEARD II studies.
The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.
Proportion of patients achieving Severity of Alopecia Tool score ≤20 increased through 68 weeks of open-label extension
The approval was based on data from the phase 2 Effisayil-2 study which included patients 12 years of age and older and weighing at least 40kg with a history of at least 2 GPP flares of moderate to severe intensity.
Among patients with atopic dermatitis and self-reported race other than White, 68.3% achieved EASI 75 at week 16.
The application is supported by data from two phase 3 trials that assessed the efficacy and safety of DFD-29 in adults with moderate to severe papulopustular rosacea.
Benzene is one of the 20 most widely used chemicals in the US, and people are exposed “mainly by breathing in air containing benzene,” according to the American Cancer Society.
Investigator Global Assessment of 0 or 1 occurred in significantly more patients receiving tacrolimus microemulsion versus placebo.
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