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
EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults
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
Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population
According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
Construction of the plant will commence in 2025 with first production expected to be in 2027
Silica is a proven and highly effective anti-caking agent that has been used for decades
The inspection conducted by EDQM at its Visakhapatnam facility
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