Drug Approval | July 26, 2024
USFDA inspects Gland Pharma’s Dundigal facility
The inspection was concluded with two 483 observations
The inspection was concluded with two 483 observations
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
The partnership will focus on creating capabilities for quickly and accurately processing vast amounts of clinical data
The discussion at the fourth session was centered on the fusion of academic rigor and industrial pragmatism as a key to pioneering solutions for sustainable and prosperous future
The integrated company delivers a broad portfolio of over 30,000 lab products across microscopy, histology, and other research areas
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
Dr. Roopal Thakkar joined Abbott/AbbVie in 2003 as part of the Physician Development Program
Felzartamab demonstrated positive interim results from the Phase 2 IgA nephropathy (IgAN) study
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