The new prefilled syringe has the same composition but removes the need for reconstitution. The Food and Drug Administration (FDA) has accepted for review the regulatory application for a new ...

Heading into 2025, the chief item on argenx’s agenda is the FDA’s April 10 target action date to decide on the approval of a prefilled syringe version of Vyvgart—also known as efgartigimod ...

SMi reports: West Pharmaceutical Services to Host a Free Exclusive Webinar on Prefilled Syringe Elastomer Components High-Quality Solutions for Sensitive Molecules, taking place on 16 th July 2020.

The pre-filled syringes industry is growing at an exponential rate. With increasing demand for self-administration, a rise in biologics, large-volume delivery and the delayed EU MDR at the ...

The trial demonstrated pharmacokinetic equivalence to the US-licensed and EU-authorized reference product, ORENCIA®. KSHB002, a 125 mg/mL pre-filled syringe injection, was evaluated in a randomized, ...

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant ...

US-based biopharmaceutical company Kashiv Biosciences has reported that a Phase I trial of its 125mg/mL pre-filled syringe injection ... to the reference product, Orencia. The randomised, open ...

London: GSK plc has announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK's Recombinant Zoster ...

The differences between PFSs and MDVs (per 1000 doses) is 324.21. MDV: Multidose vial; NA: Not available; PFS: Prefilled syringe. Prefilled syringes (PFSs) have gained market share in the USA ...

The new prefilled syringe removes the need to reconstitute separate vials prior to administration, offering a convenient option for physicians, pharmacists and other healthcare professionals who ...