The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The company will now seek final approval from NCLT, Mumbai Bench, and upon its receipt, OneSource will proceed to seek listing approvals from the BSE and NSE
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
Secretary Vaidya Rajesh Kotecha has urged senior officials to strive for the successful attainment of targets during the campaign
Agreement further expands Aptar Pharma’s leading respiratory portfolio
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients
The companies will combine Nanoform’s Biologics platform with the Celanese VitalDose Drug Delivery platform to further optimize controlled release of biologics
Konieczny has served as Interim CEO since April 2024
Multi-year collaboration focuses on development of biodegradable antimicrobial peptides with broad application possibilities in the areas of skin care and healthcare
New Phase II data show vast majority of patients experiencing no relapses or disability progression
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