Atamyo Therapeutics proclaimed that the FDA has given the green light for its ATA-100 IND application to advance into a Phase 1b/2b clinical study.

VBI Vaccines Inc. publicized that its strategic HBV collaborator, Brii Biosciences announced preliminary group-level unmasked 36-week data from a mid-term examination of a randomly assigned, placebo-controlled, and double-concealed Phase 2 investigation of BRII-179 (VBI-2601).

Johnson's Janssen Pharmaceutical Companies have disclosed encouraging preliminary findings from the tri-modality Phase 3 MARIPOSA-2 trial.

Genentech, part of the Roche Group, has revealed that the FDA has accepted to their BLA for crovalimab, an exploratory, newly-developed anti-C5 recycling monoclonal antibody.

Beam Therapeutics Inc., a firm in the biotechnology sector focusing on the creation of exact genetic treatments via base editing, declared that the first patient received BEAM-201 treatment.

Eledon Pharmaceuticals, Inc. revealed that it has administered the initial dose to the first participant in the BESTOW Phase 2 study.

uniQureN.V.,announces that their AMT-260 Gene Therapy candidate, developed for the treatment of Refractory Mesial Temporal Lobe Epilepsy, has received approval for the Investigational New Drug Application from the FDA.

Wave Life Sciences Ltd. declared today its initial CTA submission for WVE-006 in cases of alpha-1 antitrypsin deficiency AATD.

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.