News | December 12, 2025
Granules Life Sciences facility receives EIR from USFDA
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled
The FDA aims to make a decision by April 8, 2026
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first
The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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