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.
Federal Register notice: FDA announces an 11/7 advisory committee meeting to review an IceCure Medical de novo request for its ProSense Cryoablation S...
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 a guidance on submitting ANDA amendments under GDUFA 3.
Federal Register notice: FDA determines the regulatory review period for Cyclomedica Australias Technegas (technetium Tc 99m-labeled carbon), indicate...
Federal Register notice: FDA determines the regulatory review period for Marinus Pharmaceuticals Ztalmy (ganaxolone), indicated for treating seizures ...
