KORU Medical Systems Receives the US FDA Clearance for FreedomEDGE System to Deliver Rystiggo in gMG Patients

Shots: The US FDA has granted 510(k) clearance to FreedomEDGE infusion system to subcutaneously administer Rystiggo (rozanolixizumab-noli) in generalized myasthenia gravis (gMG) patients FreedomEDGE Infusion System enables efficient large-volume SC drug delivery, expanding from home use to clinic-based care to deliver life-changing therapies across various care settings The system supports SC drugs with varying viscosity, flow…

ByRidhi RastogiJanuary 30, 2026

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

Shots: The EMA approved 2 BLA and 6 New Chemical Entities in January 2024, leading to treatments for patients and advances in the healthcare industry In January 2024, the major highlighted drugs were Padcev to treat Bladder Cancer and Eylea for the treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) PharmaShots has…

BySenior EditorFebruary 21, 2024

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Shots: The approval was supported by the P-III (MycarinG) study evaluating the safety, efficacy & tolerability of Rystiggo (7 or 10mg/kg) vs PBO in gMG patients. The 1EP of the study includes a change in MG-ADL score at Day43 & 2EPs include a change in MG-C score, QMG, patient-reported outcomes at Day43 and AEs The…

ByDipanshu DixitJanuary 8, 2024

KORU Medical Systems Receives the US FDA Clearance for FreedomEDGE System to Deliver Rystiggo in gMG Patients

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

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

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