Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

Shots: The CHMP has recommended Nipocalimab as an add-on therapy to treat anti-AChR Ab+ & anti-MuSK Ab+ gMG pts (≥12yrs.) Opinion was based on the P-III (Vivacity-MG3) trial assessing nipocalimab (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC vs PBO + SoC in gMG pts (N=199; 153 were Ab +ve), which showed improved MG-ADL score…

ByRidhi RastogiSeptember 22, 2025

The US FDA New Drug Approvals in April 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2025 The US FDA has approved a total of 3 new drug including 1 new molecular entity and 2 Biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Johnson & Johnson’s…

ByDipanshu DixitMay 13, 2025

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing Trial showed superior disease control per MG-ADL…

ByDipanshu DixitMay 1, 2025

Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

The US FDA New Drug Approvals in April 2025

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

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