Delilah Alvarado

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.

Company shares doubled on Phase 2 study results suggesting its drug could become an alternative to vaccines for flu prevention.

The GOP senator objected to Secretary Kennedy's recasting of the influential advisory panel, which has sparked criticism from medical groups and Democratic lawmakers.

New members of the ACIP panel raised questions about the evidence supporting COVID vaccines, and signaled plans to look at other established shots.

The antibody treatment could compete with on-market drugs Dupixent and Ebgylss, while offering less frequent dosing.

The complaint argues Kennedy's actions to remove the COVID vaccine from the CDC's immunization schedule for pregnant people and healthy children were unlawful.

Coartem Baby is the first malaria drug available for use in newborns and small babies, filling an important gap in treatment. Dive Brief:

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for policy changes around mRNA vaccines in particular.

The biotech received a complete response letter from the FDA, but claims the issues raised by the agency are “readily addressable.” Dive Brief:

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in young children.