FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.
A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.
FDA publishes the eighth revision of a guidance on providing regulatory submissions for certain drug products in electronic format.
FDA authorizes Apples Hearing Aid Feature software to use with compatible AirPods Pro headphones to operate as an over-the-counter hearing aid for mil...
FDA approves Johnson & Johnsons Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis.
Gilead Sciences says data from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable lenacapavir show that it reduced HIV ...
GSK moves its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data.
CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and regulatory review.
