Roche heads to regulators with new autoimmune win for Gazyva
Continuing the reinvention of its cancer drug Gazyva as a treatment for immune-mediated diseases of the kidney—which resulted…
Novartis’ Pluvicto unlocks substantial new patient pool
Novartis’ blockbuster radioligand therapy Pluvicto has cleared a key milestone on its quest to hit $5 billion in…
FDA approves Pluvicto for PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC), advancing potential new standard of care across metastatic disease
Pluvicto now approved across PSMA+ metastatic prostate cancer, nearly doubling eligible patient population PSMAddition updated results show Pluvicto…
FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy
F. Hoffmann-La Roche Ltd Priority Review decision is based on phase III MAJESTY results, where Gazyva/Gazyvaro achieved significantly…
Can Novartis’ Fabhalta Strengthen Its Nephrology Franchise?
Novartis NVS announced that the FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline…
Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN
Fabhalta slowed eGFR decline by 48% vs placebo over two years, demonstrating kidney function preservation1 Clinically meaningful improvements of…
RHHBY’s Gazyva Gets FDA Priority Review for Label Expansion
Roche RHHBY announced that the FDA has granted Priority Review to the company’s supplemental biologics license application (sBLA)…
Nestle vows to eliminate artificial dyes from food this year
VEVEY, Switzerland – Nestle plans to remove artificial food colorings from all products worldwide by the end of…
Roche Gets FDA Priority Review for Enspryng in Thyroid Eye Disease
Roche RHHBY announced that the FDA has accepted and granted priority review to its supplemental biologics license application…
Roche Gets FDA Priority Review for Enspryng in Thyroid Eye Disease
Roche RHHBY announced that the FDA has accepted and granted priority review to its supplemental biologics license application…
FDA Accepts Roche’s Filing for Lunsumio VELO-Polivy in LBCL
Roche RHHBY announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of Lunsumio…
Takeda, Innovent-Lilly, Roche—Fierce Pharma Asia
Takeda tightened its pipeline in the third quarter. Innovent Biologics reported a head-to-head win against semaglutide in a…