News

FDA approved Vyvgart Hytrulo prefilled syringe for gMG and CIDP self-injection in 20–30 seconds. Human factor studies showed patients and caregivers safely administered the new formulation.
The U.S. Food and Drug Administration (FDA) on Thursday approved a new option for patients to self-inject Argenx SE’s (NASDAQ:ARGX) Vyvgart Hytrulo with a prefilled syringe (efgartigimod alfa ...
Halozyme Therapeutics, Inc. (Halozyme) announced that argenx has received US Food and Drug Administration (FDA) approval of Vyvgart Hytrulo prefilled syringe for self-injection (efgartigimod alfa and ...
In March 2025, ANI Pharmaceuticals, Inc. announced the FDA approval of Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe format. In March 2024, SCHOTT Pharma ...
The US Food and Drug Administration (FDA) has approved a prefilled syringe for self-injection of efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo, argenx) in the treatment of adults with ...
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 U.S. regulator has signed off on argenx’s prefilled syringe (PFS) version of Vyvgart Hytrulo, which allows patients to self-inject at home as opposed to undergoing infusions or making weekly ...
The Food and Drug Administration (FDA) has approved a prefilled syringe formulation of Vyvgart ® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) that allows patients to self-inject the medication.
April 10 (Reuters) - The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's (ARGX.BR), opens new tab blockbuster immune disorder drug ...
Alongside the financial details on its first-quarter performance, Regeneron also revealed that the FDA last week rejected the company’s application for a prefilled syringe version of Eylea HD.
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 ...