- In April 2025, The U.S. Food and Drug Administration (FDA) approved a prefilled syringe version of Argenx SE's immune disorder drug, Vyvgart. This approval enables at-home self-administration for patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The new formulation, branded as Vyvgart Hytrulo, utilizes efgartigimod with Halozyme Therapeutics’ delivery system and is expected to be available within two weeks at a comparable cost to the existing subcutaneous version
- In December 2024, Genentech announced that the FDA had approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe for treating wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This approval marks the first and only bispecific antibody approved for the eye, offering rapid and robust vision improvements
- In July 2024, BD (Becton, Dickinson, and Company) unveiled a next-generation glass refillable syringe designed to meet the stringent requirements of vaccine performance, including processability, cosmetics, contamination, and integrity. This innovation aims to enhance vaccine delivery and manufacturing processes
- In September 2024, Simtra BioPharma Solutions announced a $250+ million investment to expand its sterile fill/finish manufacturing facilities in Bloomington, Indiana. The new facility will house high-speed automated isolator syringe fill lines and a dedicated clinical line to support the growing demand for prefilled syringes
- In December 2020, BD (Becton, Dickinson and Company), a leading global medical technology company, announced plans to invest USD 1.2 billion over four years. This investment is made to expand and upgrade manufacturing capacity and technology for pre-fillable syringes (PFS) and advanced drug delivery systems (ADDS) at its six global manufacturing locations and open a new manufacturing facility in Europe. By the end of 2023, the new manufacturing site in Europe should be operating
