Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
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
Wanbury receives CEP approval from EDQM for launch of Dextromethorphan API
Lilly will license certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply treatment for various immunological diseases
The companies will combine Nanoform’s Biologics platform with the Celanese VitalDose Drug Delivery platform to further optimize controlled release of biologics
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative Imfinzi-based regimen in bladder cancer
First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects
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