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
Additional capacity broadens Grace’s fine chemical capabilities for API production
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager
Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility
The product combines proven efficacy of Doxylamine succinate 20 mg and Pyridoxine hydrochloride 20 mg in an Extended Release formulation
ANVISA issues CGMP to Concord Biotech’s Unit I
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