Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting ...

British drug maker GSK plc (GSK, GSK.L) announced Friday that the US Food and Drug Administration has accepted for review the ...

The new prefilled syringe has the same composition but removes the need for reconstitution, providing a more convenient option for health care providers who administer vaccines. According to the ...

On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, ...

It is thought that the FDA is probably using the preclinical data for a supplementary new drug application (NDA ... During his December 2009 presentation to the FDA–CMS (Centers for Medicare ...

DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study EPITOPE OLE data demonstrates continued improvement in treatment ...

A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could ...

A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods gained and the significance of the new drugs and biologics that these ...

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...

Plans for 2025 include a new drug application for ORLADEYO granules for children under 12 and advancements in clinical programs for Netherton syndrome and diabetic macular edema. The company's ...