FDA sets review date for Ironshore Pharmaceuticals’ ADHD drug HLD200
Ironshore Pharmaceuticals & Development, a subsidiary of Highland Therapeutics, has reached a significant milestone with the U.S. Food and Drug Administration’s (FDA) acceptance of their ... Read More
FDA approves Luxturna gene therapy for inherited vision loss
In a significant advancement for medical science, Luxturna (voretigene neparvovec), developed by Spark Therapeutics, has been approved by the U.S. Food and Drug Administration (FDA) ... Read More
Mylan launches generic Estradiol Vaginal Cream after securing FDA approval
Mylan, a global pharmaceutical company, has recently announced the U.S. Food and Drug Administration (FDA) approval of its Estradiol Vaginal Cream USP, 0.01%, a generic ... Read More
FDA approves Amgen’s Repatha for heart attack and stroke prevention
In a significant advancement for cardiovascular disease management, Amgen's Repatha (evolocumab) has received approval from the U.S. Food and Drug Administration (FDA) to prevent heart ... Read More
FDA approves ViiV Healthcare’s Juluca for maintenance treatment of HIV-1
ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK), Pfizer, and Shionogi, has received approval from the U.S. Food and Drug Administration (FDA) for its two-drug ... Read More
FDA grants accelerated approval to AstraZeneca’s Calquence for mantle cell lymphoma treatment
AstraZeneca has achieved a significant milestone with the early FDA approval of Calquence (acalabrutinib) for the treatment of adult patients with mantle cell lymphoma who ... Read More
FDA grants approval to Yescarta for treatment of certain types of lymphoma
In a significant development for lymphoma treatment, Kite Pharma, a subsidiary of Gilead Sciences, has received approval from the U.S. Food and Drug Administration (FDA) ... Read More
Lupin expands US women’s health portfolio with $150m acquisition of Symbiomix Therapeutics
Lupin Limited, a Mumbai-based generics pharmaceutical company, has strategically broadened its foothold in the women’s health sector by acquiring Symbiomix Therapeutics. The acquisition, valued at ... Read More
Spark Therapeutics’ Luxturna nears FDA approval for gene therapy treating inherited blindness
In a significant development in gene therapy, Spark Therapeutics' Luxturna (voretigene neparvovec) is on the verge of receiving FDA approval for treating blindness caused by ... Read More
Novo Nordisk’s Fiasp gains FDA approval for fast-acting insulin, enhancing diabetes management in US
Novo Nordisk, a leading Danish pharmaceutical company, has secured a significant regulatory milestone with the US FDA approval of its innovative fast-acting mealtime insulin aspart ... Read More