Biopharma | January 01, 2026
Savara resubmits FDA application for potential treatment in rare lung disease patients
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
HYMPAVZI’s safety profile was generally favorable
LYMPHIR addresses a clear clinical need in a disease with limited treatment options
The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio
It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria
Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
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