Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or ...

The approval of a new presentation enhances treatment flexibility for children with inflammatory diseases.

Gland Pharma shares rose after it secured United States Food and Drug Administration (USFDA) approval for its Abbreviated New ...

The new offering, designed specifically for prefilled syringes used in various applications, complements its 1 mL ImProject ...

HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations ...

Organon and Samsung Bioepis' HADLIMA granted FDA interchangeability designation approval for all high- and-low concentration presentations.

1,2,5 As our data shows ... approved by the FDA in 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and autoinjector. The high-concentration (40 mg/0.4 mL) formulation ...

The U.S. Food and Drug Administration (FDA) has approved a prefilled syringe format ... in two dosages — 40 USP units/0.5 mL and 80 USP units/1.0 mL — that patients can give themselves via ...

The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials. For full indications and important safety information ...