The European Medicines Agency (EMA) has published a new booklet on the safety monitoring of medicines in the European Union. It provides an overview of how the European Medicines Agency and European Union Member States work to ensure that medicines used across Europe remain safe throughout their lifecycle. The booklet is published on a new […]
Yutrepia is a dry powder formulation of treprostinil, a prostacyclin analog. It is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort. Yutrepia was was tentatively approved by the Food and Drug Administration last year (see our article here), but the agency was waiting for regulatory exclusivity of a competing product
Link: Liquidia Corporation announced on March 28, 2025, that the US Food and Drug Administration has accepted its resubmitted new drug application for YUTREPIA (treprostinil) inhalation powder. The treatment targets pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA had previously granted tentative approval for both indications (see our
On Wednesday April 26, 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, which revise and replace the existing general pharmaceutical legislation. The EU Commission’s proposed revisions include proposals to update the EU’s Regulations on Orphan Medicinal Products and Paediatric Medicines, which are very important to Europe’s population of
