The approval was based on data from the SELECT-AXIS 2 trial that included adults with active nr-axSpA who had an inadequate response or intolerance to TNF blocker therapy.
All articles by Brian Park, PharmD
Basimglurant is a potent, cell-penetrant negative allosteric modulator of mGlu5 receptors that works by lowering the perception of pain threshold.
The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study.
Posimir is a novel formulation of bupivacaine, an amide local anesthetic, designed to be administered directly into the surgical site.
Approval was based on a prospective study that evaluated the effectiveness of the Primary Relief device in 60 patients who underwent cardiac surgery.
SP-103 is a next generation triple strength formulation of ZTlido (lidocaine topical system) 1.8%.
The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October.
Under the EUA, Jynneos can be administered either intradermally for individuals aged ≥18 years or subcutaneously for individuals aged <18 years.
FlexBurst360 therapy provides pain coverage across up to 6 areas of the trunk and/or limbs and enables adjustable programming.
The approval was based on data from the phase 3 SPIRIT program, which included the SPIRIT 1 and 2 studies, as well as the first 28 weeks of an open-label extension study.