Drug Approval | September 02, 2025
FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
First Indian company to follow global recommendations in accordance with the World Health Organisation (WHO)
Facility designed to advance the next generation of imaging systems
Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives
Replicate will receive research funding and could potentially receive up to approximately US$550 million
The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users
Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
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