Adalimumab-atto is approved for seven indications on the reference product label but lacks four others that are protected by orphan product exclusivity; launch timing is unclear due 'patent dance' litigation.
With its fourth biosimilar approval, FDA has once again shown that its thinking about how to label such products continues to evolve.
In the case of Amgen Inc.'s Amjevita (adalimumab-atto), FDA took the opportunity to adjust its biosimilar labeling approach on...
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
