Infliximab Biosimilar Gets FDA Approval
The FDA has approved Avsola (infliximab-axxq; Amgen), a biosimilar to Remicade (infliximab; Janssen Biotech).
The FDA has approved Avsola (infliximab-axxq; Amgen), a biosimilar to Remicade (infliximab; Janssen Biotech).
The FDA has granted Fast Track designation for itolizumab (EQ001; Equillium) for the treatment of lupus nephritis.
Fidia Pharma USA has announced the launch of Triluron (sodium hyaluronate), a hyaluronic acid (HA) based intra-articular viscosupplement.
Ixekizumab demonstrated superiority to adalimumab in achieving simultaneous joint and skin improvement in biologic-naive patients with active psoriatic arthritis, according to data from the phase 3b/4 SPIRIT Head-to-Head (H2H) study.
Tildrakizumab-asmn demonstrated significant improvements to swollen and tender joint counts and pain in patients with active psoriatic arthritis (PsA), according to phase 2b interim results.
AbbVie announced positive topline data from the phase 3 SELECT-PsA 2 trial of upadacitinib (Rinvoq) in patients with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to ≥1 biologic disease modifying anti-rheumatic drugs (bDMARDs).
The FDA has issued a report assembled by the inter-agency Drug Shortages Task Force to determine the root causes of drug shortages, and to offer recommendations based on the insights from stakeholders in the private and public sectors to help prevent future drug shortages.
Filgotinib is an investigational, oral selective JAK1 inhibitor.
Certain types of tumor necrosis factor (TNF) agents may affect the recurrence of uveitis in Behcet disease (BD) patients, while not affecting the occurrence of uveitis in patients with ankylosing spondylitis (AS), according to research presented at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting.
The FDA has granted Breakthrough Therapy designation to nintedanib (Ofev; Boehringer Ingelheim) for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.