The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Senores Pharmaceuticals (SPI) acquired 51% stake in Zoraya Pharmaceuticals
The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
The deal reinforces GSK’s leadership in respiratory care and builds upon the company’s expanding COPD portfolio
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study
The Cranbury facility represents a strategic advancement of the company's operations in the Unted States
The inspection was carried out between May 26, 2025 and May 31, 2025
Alembic receives EIR from USFDA for facility at Panelav
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
The accelerated approval is supported by results from part 1 of the ESSENCE trial
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