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...

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...

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...

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

Clinical deep dive Disease state overview RRP is a rare condition which manifests clinically as persistent wart-like growths (papillomas) within the aerodigestive tract, primarily in the larynx,...

Regeneron has resubmitted their fully human immunoglobulin G4 (IgG4)-based CD20 x CD3 bispecific antibody, odronextamab, to the FDA for the treatment of R/R follicular lymphoma (FL) after two or...

Event will feature David Lassen, chief clinical officer

Traditional Jun. 28, 2024 – Ahzantive™ (aflibercept-mrbb) Formycon received FDA approval for Ahzantive™ as a biosimilar to Regeneron’s Eylea® (aflibercept). Ahzantive™ is a vascular endothelial...