Drug Approval | March 23, 2024
Briefs: Concord Biotech and Neuland Laboratories
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Combination shows consistent benefit across prespecified post-progression outcomes
Operations of Line II was stopped due to a fire incident earlier
A five-day inspection was concluded successfully with no critical and no major observations raised
Versavo is the first Dr. Reddy's biosimilar product to be approved and launched in the UK
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
Women emerge as the cornerstone of this monumental undertaking
The inspection was concluded with few procedural observations
The company will provide comprehensive response to USFDA for the observations
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