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 trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates
ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium
The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026
Astal estimates the collaboration will generate incremental revenue of approximately Rs. 300 crore upon implementation
The study met its primary endpoint with flying colors
CX-5461 is “the world's first and most advanced G-quadruplex (G4) stabilizer in development
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38
The cancellation underscores the regulator’s strict stance against misleading cosmetic claims
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