CDSCO Panel Approves Novartis Healthcare's Protocol Amendment to study Iptacopan Dr. Divya Colin3 May 2025 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has approved the protocol...
FDA Approves First oral Treatment for rare Glomerulopathy Dr. Kamal Kant Kohli22 March 2025 6:30 AM ISTThe US Food and Drug Administration (FDA) has approved iptacopan (Fabhalta) as the first treatment to reduce proteinuria in adults with complement 3...
Novartis oral Fabhalta receives positive EMA Committee opinion for adults with C3 glomerulopathy Ruchika Sharma3 March 2025 10:30 AM ISTBasel: Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...
Novartis Healthcare gets CDSCO Panel nod to study Iptacopan Dr. Divya Colin24 Nov 2024 5:45 PM ISTNew Delhi: The drug major Novartis Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Novartis bags USFDA accelerated approval for Fabhalta for reduction of proteinuria in primary IgA nephropathy Ruchika Sharma8 Aug 2024 11:30 AM ISTBasel: Novartis has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta (iptacopan), a...
Iptacopan significantly reduce proteinuria in patients with C3 glomerulopathy, reveals APPEAR-C3G trial Dr. Kamal Kant Kohli1 Jun 2024 7:30 AM ISTNovartis today presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta (iptacopan) at the late-breaking...
Novartis Gets CDSCO Panel Nod to Study Iptacopan in Atypical Hemolytic Uremic Syndrome Dr. Divya Colin29 May 2024 6:00 PM ISTNew Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Novartis Fabhalta gets positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria Ruchika Sharma24 March 2024 2:30 PM ISTBasel: Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...
Modify Clinical study protocol of Iptacopan study in aHUS: CDSCO Panel Tell Novartis Dr. Divya Colin17 March 2024 5:15 PM ISTNew Delhi: Reviewing the Phase IIIb clinical trial study protocol of Iptacopan, the Subject Expert Committee (SEC) functional under the Central...
Oral Iptacopan monotherapy improves outcomes in patients with paroxysmal nocturnal hemoglobinuria: NEJM Medha Baranwal15 March 2024 9:15 PM ISTFrance: A recent study has shown improved clinical and hematologic outcomes with iptacopan treatment in anti-C5-treated patients with persistent...
Novartis Gets CDSCO Panel Nod to study Iptacopan Dr. Divya Colin23 Dec 2023 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Novartis, the Subject Expert Committee (SEC) functional under the Central Drug...
Novartis gets USFDA nod for Fabhalta for adults with paroxysmal nocturnal hemoglobinuria Ruchika Sharma7 Dec 2023 11:43 AM ISTBasel: Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Fabhalta (iptacopan) as the first oral monotherapy for the...
