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DARZALEX FASPRO™ is the only subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma
Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of pediatric patients two years of age and older with Central Precocious Puberty
GlaxoSmithKline plc issued the following announcement on April 29.GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for JUBLIA® (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product's label to children six years of age and older.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy.
ONGENTYS, the First and Only Approved Once-Daily COMT Inhibitor, Decreases "Off" Time and Increases "On" Time Without Troublesome Dyskinesia When Added to Levodopa/Carbidopa in Patients with Parkinson's Disease
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its lead product Berubicin.
The U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body.
Patients ages 70 years or younger who were new to CLL treatment lived longer without disease progression with the IMBRUVICA®-based regimen compared to patients treated with a chemoimmunotherapy regimen
Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma.
CytoSorbents Corporation issued the following announcement on April 20.CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the U.S.
U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC).
Vault will make thousands of saliva tests available nationwide with RUCDR Infinite Biologics
The U.S. Food and Drug Administration (FDA) announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics' total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.
Seattle's AVM Biotechnology announces clinical trial approval for AVM0703, an exciting new drug to treat terminal no-option Non-Hodgkins Lymphoma, Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia.
The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has gone live with an initial phase of its digital pathology solution at New York's Hospital for Special Surgery (HSS), the world's leading academic medical center focused on musculoskeletal health.