The European Commission grants approval to Celltrion’s SteQeyma® (CT-P43), a biosimilar version of Stelara® (ustekinumab), for treating several chronic inflammatory disorders.
Galapagos reveals FDA approval of its IND application for the Phase 1/2 ATALANTA-1 trial of CD19 CAR-T therapy, GLPG5101, in non-Hodgkin lymphoma that has relapsed or is refractory.
Moderna, Inc. (NASDAQ:MRNA) reported that the European Commission (EC) has approved mRESVIA® (mRNA-1345), an mRNA vaccine targeting respiratory syncytial virus (RSV), for marketing.
The company will commence a Phase III clinical trial aiming to investigate the effectiveness and safety of 9MW2821 in individuals with recurrent or metastatic cervical cancer (CC).
This trial is investigating OMX-0407, a first-in-class, spectrum-selective SIK (salt-inducible kinase) inhibitor, in patients with advanced solid tumors.
Sutro Biopharma has initiated and is currently enrolling participants for its global Phase 2 trial, REFRαME-L1, which tests luveltamab tazevibulin (luvelta) in NSCLC patients with Folate Receptor-α expression.
Monopar Therapeutics revealed that it has obtained Human Research Ethics Committee (HREC) approval in Australia to initiate a Phase 1 clinical trial for its innovative radiopharmaceutical MNPR-101-Lu.
D&D Pharmatech begins Phase 2 trial for DD01, a long-lasting dual GLP-1/Glucagon receptor agonist, to assess its safety and efficacy in overweight/obese individuals with MASLD/MASH.