Press Releases

Ikena Oncology, Inc. and Inmagene Biopharmaceuticals  announced they have entered into a definitive merger agreement. In connection with the merger, Ikena has entered into subscription agreements for a $75 million private placement (the “Financing”) with a syndicate that includes new investors such as Deep Track Capital, Foresite Capital, RTW Investments, and existing Ikena investors such as BVF Partners L.P., Blue Owl Healthcare Opportunities, Omega Funds, and OrbiMed. The c

The International Society for Cell & Gene Therapy (ISCT) celebrates the US Food and Drug Administration's (FDA) landmark decision to approve Mesoblast Limited's allogenic, bone marrow-derived mesenchymal stromal cell (MSC) product, RYONCIL® (remestemcel-L) for pediatric, steroid-refractory, acute Graft-versus-Host-Disease (GvHD). This decision is a watershed moment for the MSC field, marking the first approval of an MSC therapy in the US. Around 50% of pediatric pati

YolTech Therapeutics today announced updated data from its ongoing Phase I/IIa clinical trial of YOLT-201, a first-in-class CRISPR/Cas9-based in vivo gene-editing therapy for ATTR amyloidosis. The trial has completed dosing in eight participants, including six patients with ATTR amyloidosis with polyneuropathy (ATTR-PN) and two patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM), across two dose cohorts. No Grade 3 adverse events (AEs), dose-limiting toxicities (DLTs), or serious adv

 Pfizer Inc.  today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.i The indication was approved based on a statistically significant and clinically meaningful improvement in response

Humacyte, Inc. a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has granted a full approval for SYMVESS (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. “We are very e

 Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company specializing in the development of innovative cell therapies for hard-to-treat diseases, today announced that in November, the first patient was dosed in its Phase 1 clinical trial of VIPER-101. VIPER-101 is an enabled autologous cell therapy designed to treat relapsed and/or refractory (r/r) T cell lymphoma, a severe disease with limited treatment options. VIPER-101 incorporates Vittoria’s proprietar

Santhera Pharmaceuticals announces that the health authorities of Hong Kong, China, have approved AGAMREE® (vamorolone) for the treatment of patients aged 4 years and older. Following the US FDA, EMEA, MHRA and NMPA, the approval by the Hong Kong DoH is the fifth independent approval by local health authorities and will enable patients with DMD in Hong Kong to access AGAMREE in the near future. According to the license agreement between the companies, which was first a

TargED is pleased to announce it has dosed the first participant with its groundbreaking thrombolytic drug, TGD001. This Phase 1a clinical trial will assess TGD001’s safety and tolerability in healthy volunteers. TGD001 is a first-in-class ‘fusion protein’ drug with a unique two-step mode of action, which offers patients with clotting disorders the potential of a faster, safer and more effective treatment than currently available treatments. Kristof Vercr

Clarity Pharmaceuticals a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce the expansion of its pipeline with a novel FAP-targeted radiopharmaceutical for the diagnosis and treatment of cancer. FAP is expressed on cancer associated fibroblasts (CAFs), a particular cell type found in the tumour microenvironment (cancer 'infrastructure' calle

GlycoNex, Inc. a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced that the first patient has been dosed in the Phase 3 clinical trial of its denosumab biosimilar, SPD8. This marks the initiation of a pivotal trial to evaluate SPD8 for the treatment of osteoporosis, with unblinded results expected in the second quarter of 2026. SPD8, co-developed with Mitsubishi Gas Chemical Company (MGC), is a biosimilar to Xg