Drugs Xagena
European Commission ( EC ) has approved the use of Ilaris ( Canakinumab ) in the treatment of active systemic juvenile idiopathic arthritis ( SJIA ) in patients aged 2 years and older, who have respon ...
European Commission ( EU ) has granted marketing authorization for Aubagio ( Teriflunomide ) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting mu ...
Xarelto ( Rivaroxaban ), a novel oral anticoagulant, has been approved by the European Commission ( EC ) for the prevention of atherothrombotic events ( cardiovascular death, myocardial infarction or ...
Merck Serono has announced that the European Commission ( EU ) has approved the type II variation to amend the Erbitux ( Cetuximab ) product information, updating the indication for Erbitux to the tre ...
Results for VEGF Trap-Eye ( Aflibercept ophthalmic solution; Eylea ) from the phase 3 MYRROR study in myopic choroidal neovascularization ( mCNV ) were presented. In this trial, patients receiving VEG ...
The Food and Drug Administration ( FDA ) has approved two new drugs, Tafinlar ( Dabrafenib ) and Mekinist ( Trametinib ), for patients with advanced ( metastatic ) or unresectable melanoma, the most d ...
The Food and Drug Administration ( FDA ) has expanded the use of Xgeva ( Denosumab ) to treat adults and some adolescents with giant cell tumor of the bone ( GCTB ), a rare and usually non-cancerous t ...
The FDA ( Food and Drug Administration ) has announced that it has approved heptavalent botulism Antitoxin ( A, B, C, D, E, F, G )-( Equine ) to treat patients showing signs of botulism following docu ...
The FDA ( Food and Drug Administration ) has approved Tobi Podhaler ( Tobramycin inhalation powder ) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes ...
The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with relapsing forms of multiple sclerosis.Multiple sclerosis is a chronic, inflammatory, ...
The FDA ( Food and Drug Administration ) has approved Invokana ( Canagliflozin ) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.Type 2 diabetes is the ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ultibro Breezhaler, 85 mcg/ ...
Eli Lilly has announced today that it will discontinue the phase 3 rheumatoid arthritis program for Tabalumab, an anti-BAFF ( B cell activating factor ) monoclonal antibody, due to lack of efficacy. T ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tybost, 150 mg, film-coated ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for Incresync, 12.5 mg / 45 mg, 12.5 mg / 30 mg, 25 m ...
The Food and Drug Administration ( FDA ) has approved Cimzia ( Certolizumab pegol ) for the treatment of adults with active ankylosing spondylitis ( AS ). The FDA also issued a Complete Response Lette ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Grastofil, 30 MU/0.5 ml and ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Giotrif 20 mg, 30 mg, 40 mg ...
Takeda officially notified the Committee for Medicinal Products for Human Use ( CHMP ) that it wishes to withdraw its application for a marketing authorisation for Omontys, for the treatment of sympto ...
Cangene Europe has notified the Committee for Medicinal Products for Human Use ( CHMP ) that it wishes to withdraw its application for a marketing authorisation for IXinity, for the treatment and prev ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Vectibix.The C ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Velcade ( Bort ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Tyverb ( Lapat ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Onglyza ( Saxa ...
The European Commission ( EC ) has approved extension application regarding the use of antiepileptic agent Zonegran ( Zonisamide ) in the treatment of paediatric patients. The approval extends the use ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lojuxta, 5mg, 10mg, 20mg ha ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Voncento.Voncento is recomm ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Evarrest Sealant Matrix.The ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cholib 145mg/40mg and 145mg ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lemtrada ( Alemtuzumab ) 12 ...
The European Commission has granted marketing authorisation for Tafinlar ( Dabrafenib ) as an oral targeted treatment indicated in monotherapy for unresectable melanoma or metastatic melanoma in adult ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Provenge.The indication rec ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Inflectra, 100 mg powder fo ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Remsima, 100 mg powder for ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended granting of marketing authorisations for the first two monoclonal-antibody biosimilars.Remsima a ...
Dendreon has announced that the European Commission ( EC ) has granted marketing authorization for Provenge ( autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T ) ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Somatropin Biopartners, 2 m ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended marketing authorisation for Pomalidomide Celgene ( Imnovid ) to treat patients with multiple mye ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended marketing authorisation for Tafinlar ( Dabrafenib ) for the treatment of adult patients with adv ...
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee ( PRAC ) has concluded that the benefits of Diane 35 ( Cyproterone acetate 2 mg / Ethinylestradiol 35 micrograms ) and its g ...
On 21 March 2013, Santhera Pharmaceuticals ( Deutschland ) GmbH officially notified the Committee for Medicinal Products for Human Use ( CHMP ) that it wishes to withdraw its application for a marketi ...
Retigabine ( Trobalt ) should now only be used as an adjunctive treatment for drug-resistant partial onset seizures with or without secondary generalisation in patients age 18 years or older with epil ...
Ondansetron ( brand leader Zofran ) is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of pos ...
A Europe-wide review of intravenous Iron products for iron deficiency and anaemia has recommended strengthened measures are taken to manage and minimise the risk of hypersensitivity reactions, which m ...
Use of Nitrofurantoin for urinary tract infections is contraindicated in patients with less than 60 mL/min creatinine clearance. Healthcare professionals should be aware of a patient’s current renal f ...
Physicians should no longer prescribe oral Ketoconazole for fungal infections, and should review patients’ treatment options because of a risk of liver injury. The European Medicines Agency’s Committe ...
The European Medicines Agency’s Committee on Medicinal Products for Human Use has reviewed the benefits and risks of the antiemetic Metoclopramide. The review was done at the request of the French med ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Xeljanz, intended for the ...
The European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP ) has recommended granting a marketing authorisation for a new advanced-therapy medicinal product ( ATMP ). Proven ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Erivedge 150 mg ...
