Drug Approval | June 27, 2024
Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care
Innovative technology represents a breakthrough scientific achievement for highly contagious respiratory disease
The facility was inspected from May 7 to May 17, 2024
PEKK is a high-performance polymer family used in aerospace and other demanding markets
Transaction is non-dilutive, with 100% performance-based payment through a royalty model
Renews GMP certifications for India and Malaysia sites
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The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
The company will now explore a buyer for its manufacturing site and exit in due course
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
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