The employer pays this level premium amount, with the potential for some reconciliation between the employer and the insurer at the end of the year, although small employers are often protected from any meaningful additional liability
For biosimilar developers assessing market access strategy, the Cordavis model establishes a new competitive dynamic that extends beyond price and clinical data
With respect to the newness criterion at 419.66(b)(1), FDA granted the applicant 510(k) clearance for the Axoguard HA+ Nerve Protector TM on April 7, 2023, and then granted a second 510(k) clearance for an expanded indication on October 12, 2023
While both medications involve tirzepatide, they serve distinct purposes
With Wegovy, studies show an average of 15% body weight reduction over 68 weeks