Drug Approval | June 25, 2024
Lupin receives EIR from US FDA for its Somerset manufacturing facility
The facility was inspected from May 7 to May 17, 2024
The facility was inspected from May 7 to May 17, 2024
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
There was no observation related to data integrity reported
Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea
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Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection
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