Urticaria News and Research RSS Feed - Urticaria News and Research

Urticaria are itchy, raised red areas on the skin. Urticaria are caused by a reaction to certain foods, drugs, infections, or emotional stress. Also called hives.
Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate. [More]

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy. [More]
FDA approves Xolair for treatment of chronic idiopathic urticaria

FDA approves Xolair for treatment of chronic idiopathic urticaria

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria, a form of chronic hives. [More]
FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults. [More]

Anaphylaxis Campaign provides updated information on Idiopathic anaphylaxis

Most people have heard of severe allergies, or anaphylaxis, to food, insect stings, drugs and other common substances, but sometimes no cause at all can be found for a person’s reaction – a condition called Idiopathic anaphylaxis. [More]
Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees. [More]

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s). [More]

FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration has accepted for review the Supplemental New Drug Application for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug, for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults. [More]

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Baxter International Inc. today announced that the United States Food and Drug Administration granted approval of Baxter's FEIBA [Anti-Inhibitor Coagulant Complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors. [More]
Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Genzyme, a Sanofi company, announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis, with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies. [More]
Crealta to acquire all assets of Savient Pharmaceuticals

Crealta to acquire all assets of Savient Pharmaceuticals

Savient Pharmaceuticals, Inc. ("Savient") announced that it has reached agreement on the terms of an acquisition agreement with Crealta Pharmaceuticals LLC ("Crealta") through which Crealta would acquire substantially all of the assets of Savient, including all KRYSTEXXA® assets, for gross proceeds of approximately $120.4 million. [More]
EC approves INVOKANA (canagliflozin) medication for adults with type 2 diabetes mellitus

EC approves INVOKANA (canagliflozin) medication for adults with type 2 diabetes mellitus

Janssen-Cilag International NV announced today that the European Commission has approved INVOKANA (canagliflozin) in the European Union for the treatment of adults with type 2 diabetes mellitus, to improve glycaemic control[1]. Canagliflozin is an oral, once-daily medication, which belongs to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors. [More]

FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX™ (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. [More]
FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

FDA approves Cimzia for treatment of adults with active ankylosing spondylitis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis. [More]

FDA accepts, files Genentech's sBLA for subcutaneous use of Xolair in people with CIU

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted and filed the company's supplemental Biologics License Application for subcutaneous use of Xolair (omalizumab) in people with Chronic Idiopathic Urticaria who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses. [More]
FDA approves Cimzia (certolizumab pegol) for active psoriatic arthritis

FDA approves Cimzia (certolizumab pegol) for active psoriatic arthritis

UCB announced today that the U.S. Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis. [More]

Data shows individualized regimens can help optimize prophylaxis treatment in hemophilia patients

Baxter International Inc. today announced data featuring ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method], a leading recombinant treatment available worldwide, during the 24th Annual Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Amsterdam, The Netherlands. [More]
Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

Shire's scientific data on treatments for psychiatric disorders to be presented at APA meeting

Shire plc, the global specialty biopharmaceutical company, announces that it will present scientific data in 7 poster presentations at the American Psychiatric Association 166th Annual Meeting in San Francisco, May 18-22. [More]
Boehringer Ingelheim updates HCPs, patients on COMBIVENT RESPIMAT Inhalation Spray

Boehringer Ingelheim updates HCPs, patients on COMBIVENT RESPIMAT Inhalation Spray

As part of the company's commitment to chronic obstructive pulmonary disease patients, Boehringer Ingelheim Pharmaceuticals, Inc., a leader in respiratory health, is updating healthcare professionals and patients that the transition to COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray for the maintenance treatment of COPD is nearly complete. [More]

Data from MK-5172 Phase II study for treatment of HCV genotype 1 infection to be presented at EASL meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of the latest interim data from a Phase II, multi-center, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172, for the treatment of chronic hepatitis C virus genotype 1 infection. [More]