The EC has authorized the use of Merck's KEYTRUDA® (pembrolizumab) in combination with Padcev® (enfortumab vedotin-ejfv) as an initial therapy for adults with inoperable or metastatic urothelial cancer.
This FDA approval of the ARCT-032 IND application allows the Company to commence a Phase 2 multiple ascending dose study to assess the safety, tolerability, and efficacy.
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the National Medical Products Administration (NMPA) has approved their investigational new drug (IND) application for the clinical trial of HLX17
IgGenix revealed promising data about its primary candidate, IGNX001. This candidate is an IgG4 monoclonal antibody therapy designed to treat peanut allergy.
Tolebrutinib achieves main goal in HERCULES phase 3 trial, proving to be the first to reduce disability progression in non-relapsing secondary progressive multiple sclerosis.
Grit Biotechnology gains U.S. FDA approval for GT201 investigational new drug application, a genetically modified TIL, after receiving Chinese IND approval.
On September 2, 2024, Arrowhead Pharmaceuticals (referred to as "Arrowhead") announced the results of the Phase 3 PALISADE study for plozasiran in patients with familial chylomicronemia syndrome (FCS).
Pierre Fabre Laboratories gets green light from EC for BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) combo to treat adults with advanced BRAFV600E-mutant NSCLC.