Insights+: EMA Marketing Authorization of New Drugs in August 2024

Shots: The EC has approved to 5 Biologics and 3 New Chemical Entities in August 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Johnson & Johnson’s Balversa to treat Metastatic Urothelial Carcinoma (mUC) and Takeda’s Adzynma for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) PharmaShots has compiled a list…

ByDipanshu DixitSeptember 24, 2024

NEWS

Johnson & Johnson’s Balversa (Erdafitinib) Receives the EC’s Approval to Treat Urothelial Carcinoma

Shots: The EC has approved Balversa (oral, QD) monotx. for treatment-experienced adults with inoperable or metastatic urothelial carcinoma (mUC) having susceptible FGFR3 genetic alterations Approval was supported by results of cohort 1 from the P-III (THOR) trial assessing the safety & effectiveness of Balversa (n=136) vs CT (n=130) to treat mUC with select FGFR alterations…

ByDipanshu DixitAugust 23, 2024

NEWS

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)

Shots: The CHMP has granted a positive opinion to Balversa monotx. (QD, oral) to treat inoperable mUC adults with susceptible FGFR3 mutations & previously treated with at least 1L of therapy with PD-1/PD-L1 inhibitor The opinion was based on the arm 1 of P-III (THOR) trial assessing the safety & efficacy of erdafitinib (n=136) vs…

ByDipanshu DixitJune 28, 2024

Insights+: EMA Marketing Authorization of New Drugs in August 2024

Johnson & Johnson’s Balversa (Erdafitinib) Receives the EC’s Approval to Treat Urothelial Carcinoma

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)

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