Drug Approval | April 02, 2024
AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer
Application based on results from the TROPION-Breast01 Phase III trial
Application based on results from the TROPION-Breast01 Phase III trial
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+
WINREVAIR is a breakthrough biologic for this rare, progressive disease
Combination shows consistent benefit across prespecified post-progression outcomes
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Oscotec has successfully completed phase 2 study in patients with chronic ITP last year
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
Pharma Solutions operates 10 research and development and/or production sites globally
The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
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