The U.S. Food and Drug Administration approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus”
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Approval based on clinical trials showing people treated with SKYRIZI™ (risankizumab-rzaa) every 12 weeks - four doses a year after two initial doses - achieved high levels of durable skin clearance at 16 weeks and maintained this response at one year[1-3]
Transcatheter Aortic Valve Replacement Technology for Patients with Severe Aortic Stenosis Designed to Minimize Paravalvular Leakage, Offer Controlled Delivery and Repositionability Post Deployment
KardiaMobile® Now The Only Personal ECG to Detect The Three Most Common Heart Arrhythmias
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Generic carprofen chewable tablet developed to treat osteoarthritis symptoms in dogs
A First-in-Class, Non-Surgical Solution for Obesity Approved for One-Year of Device Treatment, Offering Patients Potentially More Durable Weight Loss and Health Benefits
Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has approved abbreviated new drug application (“ANDA”) No. 208024 for Fluticasone Propionate Nasal Spray USP, 50 mcg per spray (OTC) owned by Akorn, Inc. (“Akorn”) (NASDAQ: AKRX). I
Synergistic Therapeutics LLC has recently announced issuance of a U.S. Patent for a sublingual antidepressant lozenge with Ketamine, used to treat anxiety, depression, major depressive disorder (MDD), and treatment-resistant depression (TRD).
The new Complete blood pressure monitor with EKG capability from Omron Healthcare, in partnership with AliveCor, is now available for preorder in the U.S. on Omron’s website.
Balversa is the first targeted therapy to receive approval by the U.S. Food and Drug Administration for adult patients with advanced metastatic bladder cancer with the genetic alteration called FGFR3 or FGFR2 that progressed during or after platinum-containing chemotherapy.
BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval
The Food and Drug Administration (FDA) has given tentative approval for the generic version of Sernivo Spray 0.05% from Perrigo Company.
The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).
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The U.S. Food and Drug Administration today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.
The U.S Food and Drug Administration granted a De Novo review for a device intended to be used in the spine.
Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S. Food and Drug Administration (FDA) clearance for its SIRA™ RFA Electrosurgical Device, a novel radiofrequency ablation (RFA) applicator that supplies energy for use in electrosurgery, specifically for intraoperative coagulation and ablation of soft tissue.
LSK BioPharma (or "LSKB"), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or "Hengrui"), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, announced that the Companies have received FDA clearance to initiate a clinical trial in the United States in first-line patients with advanced hepatocellular carcinoma (HCC), evaluating the safety and efficacy of LSKB's rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, in combination with Hengrui's camrelizumab (SHR-1210), a humanized anti-PD-1 monoclonal antibody currently under NDA review in China for classic Hodgkin's Lymphoma (cHL).