The campaign marks an important milestone in its journey within the pharmaceutical manufacturing industry
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
KRKA holds 51% and Laurus Labs holds 49% shareholding
This facility manufactures APIs & formulations of oncology and non-oncology products.
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
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