Final data comparing cabotegravir to Truvada for HIV prophylaxis confirms superiority. ViiV says treatment data in women may enable an all-gender approval that eluded Gilead with Descovy.

Regulators in high-income countries have a responsibility to help health authorities in low- and medium- income countries develop regulatory frameworks for cell and gene therapy products to ensure these treatments are available to all, asserts the US FDA’s biologics center’s director.

Democratic lawmakers argue the Trump administration’s interpretation of how COVID-19 testing is covered by private insurers runs contrary to the Families First Act and CARES Act. They want the administration to update a FAQ sheet that eliminates certain prerequisites that would qualify patients to be reimbursed for the tests.