FDA grants Fast Track Designation for Teva’s Emrusolmin
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development
He has been associated with the Zydus Group since 2009
Combination creates a leading, next generation claims operating system for payers, with end-to-end AI capabilities for claims, payments, care & utilization management, payment integrity, and member engagement, serving 115+ health plans
Kenox to provide formulation and development expertise in orally inhaled and nasal drug products
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Agreement further expands Aptar Pharma’s leading position in nasal delivery solutions and addresses significant unmet needs of delivering drugs locally over extended periods
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
It will focus on interface between API and formulation manufacturing, reducing carbon footprint in formulation production, creating intellectual property, training next-generation scientists, and setting new industry benchmarks
These licenses are given in areas of infectious disease diagnostics, immunodiagnostics, and vaccine development
Goyal reaffirmed the government’s commitment to facilitating market access, reducing trade barriers, and ensuring that Indian exporters remain globally competitive
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