DaHee Han

PharmD

Most Recent Articles by DaHee Han

Xolair Designated Breakthrough Therapy for Food Allergies

Xolair Designated Breakthrough Therapy for Food Allergies

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The FDA designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (eg, peanut, milk, egg, others).

Generic Version of Adcirca Now Available for Pulmonary Arterial Hypertension

Generic Version of Adcirca Now Available for Pulmonary Arterial Hypertension

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Tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, is indicated to treat pulmonary arterial hypertension to improve exercise ability.

Orenitram Decreased Risk of Morbidity/Mortality Event in PAH Trial

Orenitram Decreased Risk of Morbidity/Mortality Event in PAH Trial

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United Therapeutics announced that the Phase 3 trial of Orenitram for PAH has met its primary endpoint of delayed time to first clinical worsening event.

Omadacycline Gets FDA Committee Nod for Skin Infections, Pneumonia

Omadacycline Gets FDA Committee Nod for Skin Infections, Pneumonia

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The Committee's recommendation was based on data from the omadacycline global development program that included nearly 2000 adults in three Phase 3 studies.

FDA Panel Votes on Therapy for Nontuberculous Mycobacterial Lung Disease

FDA Panel Votes on Therapy for Nontuberculous Mycobacterial Lung Disease

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The recommendation was supported by materials developed from the ALIS New Drug Application (NDA), which included data from the CONVERT study.

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