News from the FDA/CDC
News from the FDA/CDC
FDA approves Yuflyma as ninth adalimumab biosimilar
The manufacturer Celltrion is also seeking an interchangeability designation from the FDA, tentatively expected in the fourth quarter of 2024.
News from the FDA/CDC
FDA approves autoinjector pen for Humira biosimilar, Cyltezo
The drug will be commercially available on July 1, 2023.
Latest News
FDA OKs spinal cord stimulation devices for chronic back pain
The indication for the devices now includes treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery.
News from the FDA/CDC
FDA fast tracks potential CAR T-cell therapy for lupus
The cellular therapy depletes CD19-positive B cells with the goal of ‘‘resetting’’ the immune system to achieve durable remission.
News from the FDA/CDC
FDA approves new formulation of Hyrimoz adalimumab biosimilar
The agency approved a higher-concentration formulation of Hyrimoz for its previous indications, including rheumatoid arthritis and psoriasis.
News from the FDA/CDC
FDA approves first biologic treatment for polymyalgia rheumatica
The interleukin-6 receptor antagonist sarilumab (Kevzara) will be indicated in adults who have had an inadequate response to corticosteroids or...
Feature
Vibrating pill can help treat constipation
The drug-free pill is designed for daily use.
News from the FDA/CDC
FDA approves Idacio as eighth adalimumab biosimilar in U.S.
Data for Idacio (adalimumab-aacf) showed safety, efficacy, and immunogenicity similar to Humira.
News from the FDA/CDC
FDA alert: ‘Substantial’ hypocalcemia risk with denosumab use in dialysis patients
The Food and Drug Administration sent an alert that it’s investigating an apparent link between the use of denosumab (Prolia) by patients on...
News from the FDA/CDC
FDA approves upadacitinib (Rinvoq) for sixth indication
Upadacitinib’s approval for nonradiographic axial spondyloarthritis marks the sixth indication in the United States for the Janus kinase inhibitor...
News from the FDA/CDC
FDA okays spesolimab, first treatment for generalized pustular psoriasis
The drug received priority review and had orphan drug and breakthrough therapy designation.