HORSHAM, PA. — Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and...
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ORLANDO, Fla. — Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma, today announced new data from the investigational Phase 3 MajesTEC-3 study that demonstrate the potential of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as early as second line for patients with relapsed/refractory multiple myeloma (RRMM). Results show an 83% reduction in...
SPRING HOUSE, Pa. — Johnson & Johnson Family of Companies today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN). Nipocalimab is currently...
Boston –The José Baselga Research Fund (JBRF), supported by Alexion, AstraZeneca Rare Disease, announced the initiation of the Global José Baselga Research Grant (Baselga Grant), an annual $75,000 grant to advance the treatment of prion diseases, a group of rare progressive neurodegenerative disorders. “Our family feels incredibly lucky to have...
Badalona, Spain – Multiple myeloma is a type of blood cancer that appears mainly after the age of sixty. Its incidence, therefore, increases with the aging of the population. In this pathology, the bone marrow, the porous structure within the bones that produces normal blood cells, is invaded by an...
BEDMINSTER, N.J. – Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) for JBI-802, a novel, oral, potent and selective dual inhibitor...
A federal appeals court in the U.S. has issued a mandate that effectively vacates the 2019 regulatory approval of Jacobus Pharmaceutical’s Ruzurgi for the treatment of children with Lambert-Eaton myasthenic syndrome (LEMS). The ruling, by the U.S. Court of Appeals for the 11th Circuit, directs a lower district court to...
New York, NY — The Myasthenia Gravis Foundation of America (MGFA) announces its ninth annual “MG Awareness Month” during the month of June, to raise awareness of the often misunderstood and under-diagnosed disease, myasthenia gravis (MG). MG Awareness Month is an effort by MGFA and its local chapters to raise...
SHANGHAI, China — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for the company’s product, toripalimab,...
SHANGHAI, China. — Shanghai Junshi Biosciences Co., Ltd, a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced the publication of results from the prespecified interim analysis for event-free survival (EFS) in patients with stage III non-Small Cell Lung Cancer (NSCLC) of NEOTORCH (NCT04158440)...