X4 Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for the approval of once-daily oral mavorixafor in the treatment of WHIM syndrome.
On September 6, 2023, Eli Lilly has registered a Phase III clinical trial (Study Code: ATTAIN-2) of the oral small molecule GLP-1R agonist Orforglipron (LY3502970) for the treatment of type 2 diabetes patients with obesity or overweight.
On September 7, 2023, the new indication for the injectable drug Telitacicept developed by RemeGen was accepted by the Center for Drug Evaluation (CDE) for the treatment of rheumatoid arthritis (RA).
On September 6, 2023, Shanghai Yingli Pharmaceutical announced that its PI3Kδ inhibitor, Linperlisib, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for a new indication filing.
Genentech, a member of the Roche, announced that the U.S. FDA has accepted the company's BLA for the novel complement C5 monoclonal antibody Crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Korean biotech firm Alteogen Inc. has publicized the findings of their most recent Tergase® clinical study, wherein no occurrence of ADA (inclusive of neutralizing antibodies) was found.
ILiAD Biotechnologies, LLC, a biotech firm in the clinical trial phase, which is spearheading the creation of an unparalleled, progressive pertussis vaccine, reports promising preliminary results from the CHAMPION-1 clinical trial.