Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

Shots:The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…

ByRidhi RastogiJuly 2, 2025

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RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots:The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapiesIn P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…

ByRidhi RastogiMay 27, 2025

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Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Shots:J&J has reported additional findings from P-III (Vivacity-MG3) trial & ongoing OLE assessing nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO in anti-AChR+, anti-MuSK+ & anti-LRP4+ adults (n=153) with gMGTrial showed a -4.9 QMG score improvement over 22 & 24wks. & pts were 4x more likely to sustain…

ByRidhi RastogiApril 10, 2025

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Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Shots:Remegen has reported P-III trial data assessing Telitacicept (RC18; 240mg; n=57) vs PBO (n=57) in 114 chinese gMG pts, with baseline MG-ADL score ≥6 & QMG score ≥8; trial incl. 24wk. double-blind phase followed by an open-label phase. BLA is under the NMPA’s review, with decision expected in Q2’25Trial showed 98.1% vs 12% pts achieved…

ByRidhi RastogiApril 9, 2025

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Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

Shots:Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25 Pts received an initial loading dose…

ByRidhi RastogiMarch 17, 2025

Fasikl Reports the US FDA’s 510(k) Clearance of Felix NeuroAI Wristband to Treat Essential Tremors

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG)

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

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