Most Recent Articles by DaHee Han
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).
Tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, is indicated to treat pulmonary arterial hypertension to improve exercise ability.
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.
The Committee's recommendation was based on data from the omadacycline global development program that included nearly 2000 adults in three Phase 3 studies.
The recommendation was supported by materials developed from the ALIS New Drug Application (NDA), which included data from the CONVERT study.