The FDA has made the labels consistent for combined hormonal contraceptives about the risk these products have to women who have or have had breast cancer.
The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.
Javier Gonzalez, Pharm.D., Abarca’s chief growth and commercial officer, talks about Assura, the PBM’s net cost pricing solution, which provides more predictability to drug costs and guarantees an annual fixed cost.
Pramod John, CEO, and Bhargav Raman, M.D., director, clinical product, at Vivio Health, discuss how their system can match patients to therapies based on data.
Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.
The FDA is seeking input from committee members about the phosphate lowering effect seen in trials for tenapanor, which now has the brand name of Xphozah.
The FDA is expected to make decisions on several products later this week, including mavacamten, Qelbree, meloxicam-rizatriptan, surufatinib and toripalimab.
The World Health Organization now recommends Paxlovid and Veklury for non-severe COVID-19 at high risk of hospitalization but still advises against use in mild disease with low risk of hospitalization.