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Tag: Regulatory Affairs
EMA CHMP New Medicines Recommended for Approval in 2026
EMA CHMP new medicines recommended in 2026 highlight major progress in drug appr...
Piramal Pharma Gets USFDA EIR; US Facility Inspection C...
Piramal Pharma receives a USFDA Establishment Inspection Report for its US facil...
Granules India to Strengthen Compliance Measures Follow...
Granules India plans to tighten oversight and compliance systems after receiving...
Dr Reddy’s Receives US FDA Inspection Report for Srikak...
Dr Reddy’s Laboratories has received a US FDA inspection report for its Srikakul...
Aarti Pharmalabs Receives Single Observation from US FD...
Aarti Pharmalabs has received one observation from the US FDA following an inspe...
EMA Validates Application to Expand Use of Tryngolza fo...
The EMA has validated an application to expand the use of Tryngolza (olezarsen) ...