Amicus Therapeutics has confirmed that the U.S. FDA has given the green light to Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules.

These studies focused on the outcomes of the Phase 1b/2 study carried out on patients who had relapsed/refractory multiple myeloma and were undergoing treatment with Equecabtagene Autoleucel.

Mabwell announced the initiation of a Phase Ib/II trial with the first patient dosage. The study uses their novel Nectin-4 ADC (9MW2821) in conjunction with a PD-1 inhibitor for advanced or metastatic urothelial carcinoma.

ImmunoGenesis announced the first patient treatment in their Phase 1a/1b trial using IMGS-001 at The University of Texas MD Anderson Cancer Center.

Merck has declared that a fresh BLA for sotatercept has been approved for accelerated assessment by the U.S. FDA.

STK-012 is designed specifically to activate antigen-triggered T cells, crucial for powerful anti-cancer effects, while avoiding broader activation of other lymphocytes, such as NK cells related to IL-2 toxicity.

ImmunoGen Inc. shared outcomes from two assessments of the MIRASOL Phase 3 trial. The trial evaluated safety and effectiveness of ELAHERE® in platinum-resistant ovarian cancer patients positive for the folate receptor alpha, versus chemotherapy.

Landmark Phase 3 MARIPOSA Study achieves its main goal, demonstrating clinically relevant enhancement for RYBREVANT® and Lazertinib when compared to Osimertinib in EGFR-Mut patients.

Gracell Biotechnologies has showcased updated long-term data from a continuing Phase 1 trial. This trial is assessing GC012F, a candidate for autologous CAR-T treatment that simultaneously targets CD19 and the B-cell maturation antigen (BCMA).

Elicio Therapeutics has revealed encouraging initial data related to relapse-free survival from their ongoing Phase 1 investigation of their primary asset, ELI-002.

Harpoon Therapeutics, Inc. has shared the interim outcomes of its Phase 1 clinical trial on the effect of single-agent HPN217 in treating relapsed or refractory multiple myeloma, focused on target dose groups from 2.15 to 12mg.

Akeso revealed that the FDA has approved their IND for CD47 Monoclonal Antibody (AK117) combined with Azacitidine for treating Myelodysplastic Syndromes.