The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
The Q-Switched Nd:YAG system is suitable for all skin types and offers versatility in treating dermal and epidermal pigmentation
The submission is supported by results from the Phase 3b APEX study
The performance was below anticipated levels, primarily due to external factors such as seasonal disruption that affected overall results
India Formulation sales accounted for 34.2% of total consolidated sales for the quarter
The facility includes advanced laboratories to monitor market trends, consumer needs, product innovation, and formulation improvements
LEQSELVI now available for prescription in U.S. nationwide, offering a new option for eligible patients
PRX-PLUS has a unique product feature with its deep-impacting formula
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