NATCO announces tentative approval to its ANDA for Trabectedin
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
Company appoints five new independent directors to reconstituted board
Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA
Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR
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