MARLBOROUGH, Mass. — Sumitomo Pharma America, Inc. (SMPA) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to nuvisertib (TP-3654), an oral investigational highly selective inhibitor of PIM1 kinase, for the treatment of patients with myelofibrosis (MF). Orphan Drug Designation is granted by the EMA to investigational...
treatment News
Nuvisertib (TP-3654), an investigational highly selective oral PIM1 kinase inhibitor, is being evaluated in patients with relapsed or refractory myelofibrosis (MF) – Nuvisertib demonstrated symptom and spleen responses correlating with cytokine modulation in the preliminary Phase 1/2 data recently presented at the European Hematology Association (EHA) 2025 Congress MARLBOROUGH, Mass. —...
Cambridge, Mass. — Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor, for the treatment of Ewing sarcoma. “We are delighted to have received this designation for TP-1287...
Mesalazine plus somatostatin and bifid triple viable capsules can effectively improve the clinical symptoms of patients with ulcerative colitis, according to a study in BMC Gastroenterology. Investigators sought to determine the effect of mesalazine plus somatostatin and bifid triple viable capsules on plasma inflammatory factors and T cell frequency in patients...
HONG KONG — Akeso Inc. announced the China National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) of cadonilimab (开坦尼®, PD-1/CTLA-4 bispecific antibody, AK104) in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ)...
TITUSVILLE, N.J. — Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson’s...
CAMBRIDGE, Mass. – Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for GSK4381562 (formerly SRF813) to proceed into a first-in-human clinical trial. GSK4381562 is a...
Ingelheim am Rhein, Germany – Boehringer Ingelheim today announced that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase II trial [response difference: 64.8% (CI 51.1% – 78.6%), p<0.0001]. The trial met its...
SOUTH SAN FRANCISCO, Calif. — Sutro Biopharma, Inc (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that the randomized portion (Part 2) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), is now open for enrollment, and...
PHILADELPHIA – SwanBio Therapeutics, a gene therapy company advancing AAV-based therapies for the treatment of devastating, genetically defined neurological conditions, today announced the initiation of the CYGNET study with the enrollment of the first two participants. CYGNET is a natural history study of adrenomyeloneuropathy (AMN), a form of adrenoleukodystrophy (ALD)...