Drug Approval | May 29, 2025
Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
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
Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease
The introduction of Coveris’ sleeve-to-sleeve PCR model complements sectors such as bottling where an established recycling infrastructure exists
Dupixent (dupilumab) approved as the first-ever biologic medicine in Japan for patients with Chronic Obstructive Pulmonary Disease (COPD)
EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults
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