Drug Approval | April 28, 2025
Biocon Biologics receives positive CHMP opinions for biosimilar Denosumab in Europe
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
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
YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease
WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
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