Drug Approval | June 13, 2025
USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
The company received 1 (One) observation in the Form-483
The company received 1 (One) observation in the Form-483
The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold
Honeywell Aclar film technology will enable Evertis to develop high-quality barrier packaging solutions
Globally, BRUKINSA is approved in more than 70 countries
This project builds on a previous joint funding agreement between CARBOGEN AMCIS and the same customer in April 2021
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Enhanced alignment to better serve customers across the entire drug development lifecycle under the Fujifilm Life Sciences brand umbrella with the tagline Partners for Life
AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations
The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval
BioNTech and Bristol Myers Squibb will jointly execute a broad clinical development program to evaluate and advance BNT327 across numerous solid tumor types
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