DUBLIN, Ireland — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy...
treatment News
NEWPORT BEACH, Calif. — jCyte, Inc., a pioneering biotechnology company dedicated to preserving and restoring vision in patients with retinitis pigmentosa (RP) and other degenerative retinal disorders, is pleased to announce the successful outcome of its pre-phase 3 Type B meeting with the US Food and Drug Administration (FDA) held...
SHANGHAI, China — Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration...
SHANGHAI, China — In another milestone since the implementation of CAR-T therapy at Jiahui, the first myeloma patient treated with CAR-T at Jiahui International Hospital was recently discharged two weeks after infusion. The foreign patient was first diagnosed with multiple myeloma in 2008. Despite multiple treatments including chemotherapy, immunotherapy, target...
LONDON, UK — GSK plc (LSE/NYSE: GSK) today announced the U.S. Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.1 The approval comes ahead of...
BOSTON, Mass. — Jnana Therapeutics, a clinical-stage biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced positive, statistically significant interim results from its ongoing clinical study of JNT-517 in individuals with phenylketonuria (PKU). JNT-517, a small molecule inhibitor of the phenylalanine (Phe) transporter SLC6A19,...
A novel three-drug combination achieved notable responses in patients with advanced HER2-negative breast cancer, according to new research directed by investigators from the Johns Hopkins Kimmel Cancer Center. The treatment included a histone deacetylase (HDAC) inhibitor — a drug that causes a chemical change to stop tumor cells from dividing...
HORSHAM, Pa. — Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral LAZCLUZE® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly...
HORSHAM, Pa. — Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy,...
RARITAN, N.J. — Johnson & Johnson (NYSE: JNJ), a worldwide leader in multiple myeloma therapies, today announced positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating TECVAYLI® (teclistamab-cqyv) + TALVEY® (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and TALVEY® + pomalidomide in adult patients with relapsed or refractory multiple myeloma...