Drug Approval | September 04, 2025
Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
This year’s edition will witness participation of over 700 Indian exporters showcasing their products and services; 500+ overseas delegates representing more than 120 countries; 20,000 domestic visitors; and 8,000+ B2B meetings
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site's capabilities
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