Drugs Xagena
The FDA ( Food and Drug Administration ) has approved the inclusion of efficacy and safety data from the TOWER and TOPIC studies of once-daily, oral Aubagio ( Teriflunomide ) in the product’s U.S. lab ...
The Food and Drug Administration ( FDA ) has approved Otezla ( Apremilast ), oral, selective inhibitor of phosphodiesterase 4 ( PDE4 ), for the treatment of patients with moderate to severe plaque pso ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Keytruda ( Pembrolizumab ) for treatment of patients with advanced or unresectable melanoma who are no longer responding to ...
The European Commission has granted marketing authorization for Zydelig ( Idelalisib ), 150 mg tablets, a first-in-class oral treatment for two incurable blood cancers, chronic lymphocytic leukemia ( ...
RPC1063 is a novel, oral, once daily, specific and potent modulator of the sphingosine 1-phosphate 1 receptor ( S1P1R ) pathway, which is a validated G protein-coupled receptor ( GPCR ) target for the ...
Acute myeloid leukaemia ( AML ) is an aggressive and devastating blood cancer. It predominantly affects people over 60 and is one of the most common adult leukaemias in the Western World. The current ...
The FDA ( Food and Drug Administration ) has approved Velcade ( Bortezomib ) for the retreatment of adult patients with multiple myeloma who had previously responded to Bortezomib therapy and relapsed ...
The FDA ( Food and Drug Administration ) has approved a supplemental New Drug Application ( sNDA ) for the once-daily use of Promacta ( Eltrombopag; Europe: Revolade ) in patients with severe aplastic ...
The European Commission ( EU ) has approved the use of Avastin ( Bevacizumab ) in combination with Paclitaxel, Topotecan, or Pegylated liposomal doxorubicin chemotherapy as a treatment for women with ...
The FDA ( Food and Drug Administration ) has granted priority review designation for Ivabradine for the treatment of chronic heart failure ( HF ). Ivabradine is an oral drug that inhibits the If cu ...
The Food and Drug Administration ( FDA ) has approved a supplement to expand the indication for Lumizyme ( Alglucosidase alfa ). Lumizyme manufactured at the 4000L scale is now indicated for all Pompe ...
The FDA ( Food and Drug Administration ) has approved Cerdelga ( Eliglustat ) for the long-term treatment of adult patients with the type 1 form of Gaucher disease, a rare genetic disorder. Gaucher d ...
The FDA ( Food and Drug Administration ) has approved a Supplemental New Drug Application ( sNDA ) for Eliquis ( Apixaban ) for the treatment of deep vein thrombosis ( DVT ) and pulmonary embolism ( P ...
Paracetamol ( Acetaminophen ) poisoning is common worldwide. It is treated with intravenous Acetylcysteine, but the standard regimen is complex and associated with frequent adverse effects related to ...
A retrospective cohort study has evaluated the effect of anesthesia type on the risk of in-hospital mortality among adults undergoing hip fracture surgery in the United States. Participants were 73 ...
The objective of a study was to describe rates and risk factors for prolonged postoperative use of opioids in patients who had not previously used opioids and undergoing major elective surgery. The ...
Eliquis ( Apixaban ) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Apixaban decreases thrombin generation and blood clot formation. Eliquis is ap ...
Stivarga ( Regorafenib ) has been approved by the European Commission ( EC ) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors ( GIST ) who progressed ...
Eylea ( Aflibercept ) injection has been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema ( DME ). Diabetetic macular edema is the leading caus ...
Kalydeco ( Ivacaftor ) is the first medicine to treat the underlying cause of cystic fibrosis in people with specific mutations in the CFTR gene. Known as a CFTR potentiator, Ivacaftor is an oral me ...
Hydroxychloroquine ( Plaquenil ) is indicated for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and malaria ( acute attacks and suppressive treatment ). Hypoglyce ...
Six Canadian cases of aortic thrombosis have been reported in cancer patients after initiation of treatment with Cisplatin, in addition to 15 published international cases. In many of these patients, ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive scientific opinion in accordance with Article 58 of Regulation ( EC ) No 726/2004, for the medicinal product Hemopros ...
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 Nerventra, intended for th ...
The European Medicines Agency ( EMA ), the Committee for Medicinal Products for Human Use ( CHMP ), and the European Commission ( EC ) have granted market authorization renewal for Angiox ( Bivalirudi ...
A phase III clinical trial ( Study 332 ) of AMPA receptor antagonist Perampanel ( Fycompa ) has met its primary endpoints in patients with primary generalized tonic-clonic ( PGTC ) seizures, one of th ...
The FDA ( Food and Drug Administration ) has approved Sivextro ( Tedizolid phosphate ), a new antibacterial drug, to treat adults with skin infections. Sivextro is approved to treat patients with a ...
The FDA ( Food and Drug Administration ) has approved Afrezza ( Insulin human ) inhalation powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezz ...
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 Reasanz, intended for the ...
The FDA ( Food and Drug Administration ) has approved Beleodaq ( Belinostat ) for the treatment of patients with peripheral T-cell lymphoma ( PTCL ), a rare and fast-growing type of non-Hodgkin lympho ...
Dimethyl fumarate ( BG-12, Tecfidera ) is a new oral drug approved by FDA ( Food and Drug Administration ) and EMA ( European Medicines Agency ) for relapsing-remitting multiple sclerosis ( RRMS ). ...
The FDA ( Food and Drug Administration ) has approved Entyvio ( Vedolizumab ) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Cr ...
Multiple myeloma, a cancer of white blood cells predominantly affecting the bone marrow, impacts approximately 1 to 5 in every 100,000 people worldwide each year. With a five-year survival rate of 44% ...
The FDA ( Food and Drug Administration ) has approved Eloctate, antihemophilic factor ( recombinant ), Fc fusion protein, for use in adults and children who have hemophilia A. Eloctate is the first ...
The FDA ( Food and Drug Administration ) has approved the first generic versions of Celebrex ( Celecoxib ) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term ( acute ) pain, an ...
The FDA ( Food and Drug Administration ) has approved Siltuximab ( Sylvant ), for the treatment of patients with multicentric Castleman’s disease ( MCD ) who are human immunodeficiency virus ( HIV- ) ...
Pradaxa ( Dabigatran etexilate ) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ). The FDA ( F ...
The European Commission has granted marketing authorisation for Empagliflozin ( Jardiance ), a sodium glucose cotransporter 2 ( SGLT2 ) inhibitor. Empagliflozin has been approved for the treatment of ...
The FDA ( Food and Drug Administration ) has approved Zontivity ( Vorapaxar ) tablets to reduce the risk of myocardial infarction, stroke, cardiovascular death, and need for procedures to restore the ...
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 Translarna, intended for t ...
Novartis has announced that the European Commission ( EC ) has approved the use of Xolair ( Omalizumab ) as an add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent ...
Empagliflozin is an oral selective SGLT-2 inhibitor that acts by blocking the reabsorption of glucose in the proximal tubules in the kidneys, and promotes excretion of excess glucose in the urine. ...
The aim of this study was to evaluate the safety and tolerability of Sitagliptin ( Januvia ) 100 mg/day in elderly patients with type 2 diabetes mellitus. A post hoc pooled analysis of 25 randomize ...
Pfizer has announced top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials ( OPT ) Program, OPT Pivotal #1 ( A3921078 ) and OPT Pivotal #2 ( A3921079 ), evaluating ...
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 Adempas, 0.5 mg, 1 mg, 1.5 ...
Novartis has announced that the Data Monitoring Committee ( DMC ) unanimously recommended early closure of the PARADIGM-HF study, indicating patients with chronic heart failure with reduced ejection f ...
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 Masiviera, intended for th ...
The FDA ( Food and Drug Administration ) Cardiovascular and Renal Drugs Advisory Committee ( CRDAC ) voted against approval for Serelaxin ( Reasanz ) for the treatment of acute heart failure ( AHF ). ...
The FDA ( Food and Drug Administration ) granted accelerated approval of Northera ( Droxidopa ) for the treatment of symptomatic neurogenic orthostatic hypotension ( NOH ). Northera is the first and o ...
The Food and Drug Administration ( FDA ) has approved Vimizim ( Elosulfase alfa ), the first FDA-approved treatment for mucopolysaccharidosis type IVA ( Morquio A syndrome ). Morquio A syndrome is a r ...
