Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results. Oral products heavily contaminated with yeast, mold, and aerobic...
treatment News
RARITAN, N.J. — Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor...
KRAKOW, Poland — Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the first patient has been dosed with the study drugs in a Phase II clinical trial investigating RVU120 in combination with venetoclax for...
KRAKOW, Poland — Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the first patient has been dosed with the study drug in a Phase II clinical trial investigating RVU120 as a monotherapy for the...
KRAKOW, Poland – Ryvu Therapeutics (WSE:RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the U.S. Food and Drug Administration, FDA, has placed a partial clinical hold on the first in human phase Ib, dose escalation...
SEONGNAM, South Korea — Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for RZ-001, in the treatment of patients with Hepatocellular carcinoma (HCC). The ODD granted to RZ-001...
SEOUL, South Korea — S.BIOMEDICS Co., Ltd. (KOSDAQ: 304360) announced that it has successfully completed the brain transplant of TED-A9 (hESC-derived dopaminergic progenitors) for Phase 1/2a study for treating Parkinson’s disease. The clinical trial was conducted on 12 participants who have been diagnosed with Parkinson’s disease for more than 5...
CAMBRIDGE, Mass.– Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to SAGE-718 for the treatment of Huntington’s disease (HD). SAGE-718 is in development as a...
SHANGHAI, China — Gannex Pharma Company Ltd, a wholly-owned company of Ascletis Pharma Inc., announced that its strategic partner, Sagimet Biosciences Inc., today reported positive topline results from Sagimet’s FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed non-alcoholic steatohepatitis (NASH) patients with stage 2 or stage 3...
SOMERVILLE, Mass. — Sail Biomedicines, Inc., a Flagship Pioneering company and leader in RNA-based programmable medicines, today provided an update on its research funded by the Cystic Fibrosis Foundation (CF Foundation), with preclinical data that suggest that Sail’s Endless RNA™ (eRNA™) may offer the potential to treat the 10%-15% of...