Zydus Lifesciences gets 10 observations from USFDA for Jarod injectable facility
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
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Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies
Commercial terms include research funding and milestones and/or royalty payments to Evotec based on the success of the program
The campaign marks an important milestone in its journey within the pharmaceutical manufacturing industry
NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections
Longest survival follow-up ever reported for immunotherapy treatment in this setting
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
Global Phase-3 study initiation expected in the second half of 2024
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