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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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...
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, 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)...
SHANGHAI, China — Shanghai Junshi Biosciences Co., Ltd, a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the Singapore Health Sciences Authority (HSA) had accepted the New Drug Application (NDA) for toripalimab, both in combination with cisplatin and gemcitabine for the first-line...
Tokyo, Japan – Cervical cancer is among the most common malignancies affecting women worldwide. In 2020 alone, approximately 600,000 women were diagnosed with this disease, and over 314,000 died from it. In 99% of the cases, cervical cancer cells harbor human papilloma virus (HPV), and thus, HPV vaccines are an...
In this multicenter randomized controlled trial, screening uptake of FIT was not different than screening uptake of colonoscopy among FDR with a high-risk family history of non-syndromic CRC. In addition, the detection rate of advanced colorectal neoplasia was significantly higher among subjects undergoing screening colonoscopy than in those receiving FIT...