treatment News

CARLSBAD, Calif. — Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for olezarsen for severe hypertriglyceridemia (sHTG). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. “Current...
INDIANAPOLIS, Indiana — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved...
SUZHOU, China, and ROCKVILLE, Md. — Ascentage Pharma, a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that olverembatinib (R&D Code: HQP1351) has been included in the latest guidelines from the National Comprehensive Cancer Network (NCCN) for the management...
SEATTLE, Washington — Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros’ investigational inhibitor of MASP-3, the key and most proximal activator of the alternative pathway of...
ROCKVILLE, Md. — OncoC4, Inc. announced that the first patient with metastatic castration resistant prostate cancer (“mCRPC”) has been dosed in a Phase 1/2 trial evaluating the anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) in combination with radioligand therapy, lutetium (177Lu) vipivotide tetraxetan (Pluvicto®). BNT316/ONC-392 is being jointly developed by BioNTech and...
ROCKVILLE, Md. — OncoC4 announced today that China’s National Medical Product Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for gotistobart (BNT316/ONC392) for the treatment of patients with squamous non-small cell lung cancer (sqNSCLC) who have progressed on prior standard immuno-oncology therapies (IO). Gotistobart is a next-generation anti-CTLA-4 antibody candidate which is being...
BOTHELL, WA, and VANCOUVER – OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced the final results of a Randomized Phase 2 Trial presented during an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. Analyses indicated a survival benefit in patients treated with OGX-011 in combination with docetaxel...
Background and Aims Hepatocellular carcinoma (HCC) is a highly aggressive tumor with limited treatment options and high mortality. Senecavirus A (SVA) has shown potential in selectively targeting tumors while sparing healthy tissues. This study aimed to investigate the effects of SVA on HCC cells in vitro and in vivo and to elucidate...
SAN DIEGO, Calif. — Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced that a Type C meeting with the U.S. Food and Drug Administration (FDA) has resulted in...