The iStent platform uses tiny surgical implants to lower eye pressure by restoring the eye’s natural fluid drainage system in patients with glaucoma
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population
AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
YESINTEK is indicated for the treatment of adults and children from the age of 6 years and olde
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
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