The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
The wP-IPV-based hexavalent vaccination is an innovative immunization alternative to the current pentavalent and standalone IPV vaccines
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
ALS patients experience neuroinflammation and rapid neurodegeneration
Konieczny has served as Interim CEO since April 2024
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab
Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry
The new facility further improves the operational efficiency and readies the site for the completion of the new large-scale production plant
Phase 3 study results will form the basis for future discussions with global regulatory authorities
MyClad is a global Phase III study evaluating the efficacy and safety of cladribine capsules for the treatment of generalized Myasthenia Gravis (gMG)
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