Agents in late-stage development for the treatment of hepatitis C.
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.
KFF: Healthcare Affordability is an Election Issue
The economy and healthcare costs are the issues voters want to hear about going into the 2024 presidential election, finds a survey by KFF.
FDA Grants Priority Review to Dupixent in COPD
If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. The target action date is June 27, 2024.
Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid
Avalere’s Kolton Gustafson talks about CMS’ new model for negotiating outcomes-based agreements for sickle cell gene therapies for patients in state Medicaid programs.
FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma
Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.
FDA Sets Review Date for Linvoseltamab for Advanced Multiple Myeloma
Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024
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