News from the FDA/CDC
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.
News from the FDA/CDC
COVID to blame as U.S. life expectancy falls
The overall drop took national life expectancy from 78.8 years in 2019 to 77 years in 2020.
News from the FDA/CDC
FDA approves adalimumab-bwwd biosimilar (Hadlima) in high-concentration form
The 100-mg/mL version of adalimumab-bwwd (Hadlima) is indicated for the same seven conditions as its 50-mg/mL counterpart.
News from the FDA/CDC
Ustekinumab becomes second biologic approved for PsA in kids
The approval is based on an extrapolation of data from adult trials in active psoriatic arthritis and adult and pediatric studies in moderate to...
News from the FDA/CDC
FDA approves belimumab for children with lupus nephritis
Children with lupus-related kidney damage can now receive the B cell–reducing therapy that adults with lupus nephritis have been able to get for...
News from the FDA/CDC
FDA grants emergency authorization for Novavax COVID vaccine
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19.
News from the FDA/CDC
FDA adds RA indication for Riabni rituximab biosimilar
Riabni is the second rituximab biosimilar to be approved for rheumatoid arthritis in the United States.
News from the FDA/CDC
FDA authorizes Pfizer’s COVID booster for kids ages 5 to 11
“The omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects,...
News from the FDA/CDC
Upadacitinib earns FDA approval for ankylosing spondylitis
Janus kinase inhibitor offers oral option for patients who have who have had an insufficient response or intolerance with one or more tumor...
News from the FDA/CDC
CDC panel lists reasons to get second COVID booster
One panelist said she was concerned about the potential for “booster fatigue.”