The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to ...
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Novartis’ Xolair (omalizumab) as an add-on therapy for the treatment of chronic spontaneous ...
Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted and filed the company's supplemental biologics license application (sBLA) for subcutaneous use of Xolair (omalizumab) in ...
Novartis has received an approval from the European Commission for its Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). Lucentis is a ...
The USFDA has approved Novartis' Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients with two years age and more. The first interleukin-1 beta inhibitor is the only treatment approved ...
c (tobramycin inhalation powder) 28mg per capsule has obtained FDA approval for the treatment of bacterial lung infection in certain cystic fibrosis (CF) patients. TOBI Podhaler is new non-nebulized formulation and delivery system of ...
Dendreon Corporation has sold its immunotherapy manufacturing facility (IMF) in Morris Plains, New Jersey, US, to Novartis Pharmaceuticals for $43m. In early 2012, Dendreon had decided to bring down Provenge production at the facility as ...
Tags: Novartis, Dendreon immunotherapy, manufacturing facility, Medicine
Novartis has obtained the US Food and Drug Administration (FDA) approval for a new 13.3 mg/24 h dosage strength of its Exelon Patch (rivastigmine transdermal system), designed to treat patients with mild to moderate Alzheimer's disease. ...
Tags: Alzheimer's disease, Novartis Pharmaceuticals, Exelon Patch
Novartis has planned to update the Rasilez's labelling to include contraindications against combined use with a number of products. The company will follow the advice of the EMA's Committee for Medicinal Products for Human Use (CHMP) in ...
Tags: Novartis, CHMP, Rasilez's labelling
Novartis has announced a label change for Gilenya in the US, to include cardiovascular monitoring, while the EMA has called for similar changes in Europe. The US label changes are the result of discussions with the FDA, following ...
Validus Pharmaceuticals and Wood Creek Capital Management have acquired the US rights to six product lines from Novartis Pharmaceuticals Corporation (NPC). The acquired six product lines include Lopressor (metoprolol tartrate USP) ...