Drug Approval | February 21, 2026
FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer
The NDA filing is supported by results from the phase III evERA Breast Cancer study
The NDA filing is supported by results from the phase III evERA Breast Cancer study
ANYRA is India’s first indigenously developed Aflibercept 2 mg biosimilar
The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma
If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
This marks the second indication for which gumokimab has gained NDA review acceptance
The researchers removed a chemical group commonly used in previous NK1R drugs and replaced it with a novel molecular scaffold
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
Lupin has bolstered its diabetes and obesity portfolios by securing an agreement for Bofanglutide, a GLP-1 receptor agonist developed by Gan & Lee Pharmaceuticals
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