Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US
The company has received five final approvals
Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis
The product is expected to be launched in December 2023
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
The plant is yet to start commercial operations
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
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