SAN FRANCISCO, Calif. — FibroGen, Inc. (NASDAQ: FGEN) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS). “The Orphan Drug Designation granted to roxadustat for MDS underscores the significant...
treatment News
Manchester, UK – Babies and toddlers with a rare and fatal genetic condition can now receive life-saving treatment on the NHS for the first time. This follows clinical research studies first carried out at the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) at Royal...
CAMBRIDGE, Mass. & LEICESTER, England — RS Oncology (RSO), a clinical stage biotechnology company developing innovative therapies to eradicate mesothelioma and other diseases, today announced the successful dosing of the first patient in the Phase 2 dose expansion portion of its United Kingdom multicenter study (MITOPE; NCT05278975). Malignant pleural effusion...
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...
KRAKOW, Poland — Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focused on novel therapies targeting emerging oncology indications, announces its involvement in the MEDWAY project with a new non-commercial academic Phase I study to evaluate the CDK8/19 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive...
RARITAN, N.J. — Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with head and neck squamous cell carcinoma that is recurrent or metastatic and human papillomavirus...
RARITAN, N.J. — Johnson & Johnson (NYSE:JNJ) today announced new longer follow-up results from the investigational Phase 1b/2 OrigAMI-1 study evaluating amivantamab-vmjw, a bispecific antibody targeting epidermal growth factor receptor (EGFR) and MET, in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. The encouraging anti-tumor activity, durable...
BARCELONA, Spain — Johnson & Johnson (NYSE:JNJ) today announced new analyses from the Phase 3 MARIPOSA study showing that first-line treatment with RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly reduces the development of epidermal growth factor receptor (EGFR)– and MET-driven resistance compared with osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC) with exon...
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...
Median overall survival not yet reached with projected improvement of more than one year versus osimertinib RARITAN, N.J. — Johnson & Johnson today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw)...