Pharmaceutical Business Review

JULY 3, 2025

This sBLA seeks to update the US product label reflecting the results from the Phase III ZENITH trial. Winrevair was initially approved in 2024 to treat adult people with pulmonary arterial hypertension (PAH, Group 1 PH) for improving exercise capacity, WHO functional class (FC), and minimise clinical worsening events risk.

Research Laboratories 52

Research Laboratories Labelling 52

Express Pharma

APRIL 17, 2023

In December 2022, the company announced positive results for PRA023 from ARTEMIS-UC, a Phase 2, placebo-controlled, study evaluating safety and efficacy in patients with moderate to severely active UC and APOLLO-CD a Phase 2A, open-label, study evaluating safety and efficacy in patients with moderate to severe CD.

Immunity 98

Immunity Immunization Research Laboratories Labelling 98

Pharmaceutical Business Review

JULY 15, 2024

Following positive results from the open-label Phase Ib/IIa AMARONE study in patients with DME and NVAMD, Restoret is poised to progress into a significant Phase IIb/III trial for diabetic macular edema (DME) in the latter half of 2024.

Research Laboratories 59

Research Laboratories Diabetes Labelling 59

Express Pharma

MAY 9, 2023

This partnership started with select Agilent instruments being independently audited for the organisation’s Accountability, Consistency, and Transparency (ACT) Environmental Impact Factor Label. Initially, we began by partnering with My Green Lab on the organisation’s ACT Environmental Impact Factor Label programme.

Packaging 98

Packaging Labelling Pharmaceutical Manufacturing Research Laboratories 98