The FDA granted a Priority Review for zoliflodacin, a first-in-class, spiropyrimidinetrione oral antibiotic by Innoviva, for the treatment of uncomplicated gonorrhea in adults and pediatric...

June 29, 2026: oxylanthanum carbonate Veligrotug is an anti-insulin-like growth factor-1 receptor (IGF-1R) antibody developed by Viridian and submitted to the FDA for the treatment of thyroid eye...

Proposed indications Epstein-Barr virus-positive (EBV+) post-transplant lymphoproliferative disease (PTLD) United States (U.S.) Food and Drug Administration (FDA) approval timeline Jan. 15, 2025...

Copy to clipboard Copied! September 27, 2024 At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep...

Proposed indications Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome FDA approval timeline April 5, 2026 (review extended) Breakthrough Therapy Fast Track Orphan Drug Priority...

Vanda Pharmaceuticals submitted the atypical antipsychotic agent milsaperidone to the FDA for the treatment of bipolar I disorder and schizophrenia. Milsaperidone is an active metabolite of Vanda’s...

Pipeline (late-stage development) NAME MANUFACTURER ROUTE OF ADMINISTRATION MECHANISM OF ACTION PROPOSED/STUDIED INDICATION STATUS Aurora-GT United IV Gene therapy; autologous endothelial...

Shortages in the manufacturing chain have led to label hopping and an increase in off-label use