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FDA approves a biosimilar and loses a commissioner in March.
Bausch’s second generation Type 529 is a semi-automatic IV bag filling and closing machine designed for aseptic packaging of infusions, parenteral drugs, and other fluids with a fully integrated automatic closing system to eliminate possible contamination.
Care needs to be made to match the method of limit determination to the analytical method.
Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.
Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.
As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.
Big service providers get bigger faster thanks to Big Pharma.
Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.
The agency has recommended granting marketing authorization for Opdivo.
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.