Drug Approval | October 27, 2022
USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
The CRL did not identify any outstanding scientific issues with the product.
The CRL did not identify any outstanding scientific issues with the product.
Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib
Pluvicto and Scemblix launches are progressing well and we are awaiting data in earlier lines of therapy.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Plans to double its manufacturing footprint to bolster the growth
The company increases its efficiency and is able to face the growing demand for its services.
Study achieves primary endpoint of radiographic progression-free survival
The reduction in force will result in financial savings of approximately $50 million annually beginning in 2023
Glenmark is the first company in India to launch Thiazolidinedione Lobeglitazone (0.5 mg).
The inspection concluded with no observation (FDA-483) issued.
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