Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Agencies and drugmakers are struggling to generate consistent standards and regulatory criteria for evaluating autologous cell therapies.
European Commission Approves Merck's Keytruda-Chemo Combination for Advanced TNBC Patients
The approval makes Merck's PD-1 inhibitor available to European TNBC patients whose tumors express PD-L1 with a combined positive score of at least 10.
BMS' Opdivo-Chemo Regimen Garners EC Approval for PD-L1-Positive Gastroesophageal Cancer
The European approval is more restrictive than the approval in the US, though regulators reviewed data from the same trial.
Menarini Group, Radius Health Advance Regulatory Plans for Elacestrant Breast Cancer Therapy
The drug improved progression-free survival over standard of care in ER-positive, HER2-negative advanced breast cancer patients with or without an ESR1 mutation.
EQRx, NHS England Sign MOU to Facilitate Access to Cancer Drugs
Additionally, two of EQRx's cancer drugs have received innovative passport designations, putting them on an expedited regulatory path to market.