Centocor submits Simponi sBLA
Centocor has submitted the sBLA seeking to expand the Simponi (golimumab) physician label to include inhibiting the progression of structural damage, inducing major clinical response (MCR) and maintenance
The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) from Pfizer and Valneva for their Lyme disease vaccine candidate, PF-07307405.