FDA Accepts sBLA for Bimzelx to Treat Hidradenitis Suppurativa Based on Phase III Trial Data
April 4th 2024In the Phase III BE HEARD I and BE HEARD II trials, a greater proportion of patients with moderate-to-severe hidradenitis suppurativa who were administered Bimzelx achieved the primary endpoint of clinically meaningful improvements in HiSCR50.
Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma
March 19th 2024Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.
Phase III THARROS Trial to Evaluate Impact of Breztri Aerosphere on Cardiopulmonary Outcomes in COPD
March 14th 2024THARROS trial investigators seek to provide first-of-its-kind evidence supporting a strategy of comprehensive cardiopulmonary risk reduction with a triple therapy in patients with chronic obstructive pulmonary disease.
Results of Phase III Trial Show Promise of Potential First-in-Class Treatment for Dry Eye Disease
February 28th 2024PL9643 ophthalmic solution is a melanocortin agonist with a novel mechanism of action that produced a clinically meaningful and statistically significant reduction in pain associated with dry eye disease.
FDA Approves New Biweekly Reduced Dosing of Tecvayli Based on Phase I/II MajesTEC-1 Trial Data
February 21st 2024The Phase I/II MajesTEC-1 trial (NCT03145181; NCT04557098) evaluated Tecvayli (teclistamab-cqyv) at a reduced dose of 1.5 mg/kg administered every two weeks in patients with relapsed/refractory multiple myeloma.