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Pharmacodynamic and safety data from a Phase 2 proof-of-concept study of its investigational factor Xa inhibitor antidote Andexanet alfa ( PRT4445 ) in healthy volunteers who were administered the fac ...


The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval of Iclusig ( Ponatinib ) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leu ...


The FDA ( U.S. Food and Drug Administration ) has approved Picato ( Ingenol mebutate ) gel ( 0.015%, 0.05% ) for the topical treatment of actinic keratosis. Actinic keratosis is a precancerous condi ...


The European Commission ( EC ) has granted marketing authorisation for Flutiform ( Fluticasone propionate / Formoterol fumarate ), a new combination therapy for the maintenance treatment of asthma, in ...


Currently, there are no Factor X inhibitors approved for indication to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. There are three P2Y12 inhibitors ...


The FDA ( Food and Drug Administration ) has approved Stribild ( Elvitegravir 150 mg / Cobicistat 150 mg / Emtricitabine 200 mg / Tenofovir disoproxil fumarate 300 mg ), a complete once-daily single t ...


The European Commission has granted marketing authorisation to Zinforo ( Ceftaroline fosamil ), a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated skin an ...


Bayer HealthCare has announced that Eylea ( Aflibercept solution for injection ), also known as VEGF Trap-Eye, has been approved by the European Commission ( EU ) for the treatment of patients with ne ...


Forxiga ( Dapagliflozin ) is the first SGLT2 ( sodium/glucose cotransporter 2 ) class drug. Forxiga has obtained marketing approval by the European Commission ( EC ) for the treatment of type 2 diabet ...


European Commission has granted Votrient ( Pazopanib ) marketing authorisation for the treatment of patients with advanced soft tissue sarcoma ( aSTS ) who have received prior chemotherapy or have pro ...


European Commission has granted marketing authorization to Jentadueto, which combines the DPP-4 inhibitor, Linagliptin and Metformin in a single tablet. Linagliptin and Metformin hydrochloride is a ne ...


The FDA ( Food and Drug Administration ) has approved Myrbetriq ( Mirabegron ) extended-release tablets for the treatment of overactive bladder ( OAB ) with symptoms of urge urinary incontinence, urge ...


Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. ...


The FDA ( Food and Drug Administration ) has approved Kyprolis ( Carfilzomib ) to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade ...


The American College of Physicians ( ACP ) has developed a clinical practice guideline to present the evidence and provide clinical recommendations on the comparative effectiveness and safety of type ...


The FDA ( Food and Drug Administration ) has approved Xtandi ( Enzalutamide ) to treat men with late-stage ( metastatic ) castration-resistant prostate cancer that has spread or recurred, even with me ...


European Commission ( EC ) has approved oral anticoagulant Xarelto ( Rivaroxaban ) for the treatment of pulmonary embolism ( PE ) and the prevention of recurrent deep vein thrombosis ( DVT ) and pulmo ...


The FDA ( Food and Drug Administration ) has approved the anti-clotting drug Eliquis ( Apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots ( systemic embolism ) in p ...


The FDA ( Food and Drug Administration ) has approved Pertuzumab injection ( Perjeta ) for use in combination with Trastuzumab and Docetaxel for the treatment of patients with HER2-positive metastatic ...


The FDA ( Food and Drug Administration ) has approved Synribo ( Omacetaxine mepesuccinate ) to treat adults with chronic myelogenous leukemia ( CML ).An estimated 5,430 people will be diagnosed with c ...


On 18 October 2012, the CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Betmiga ...


Votubia is a medicine that contains the active substance Everolimus. It is available as tablets ( 2.5, 5, 10 mg ). Votubia is used to treat the following benign tumours caused by the genetic disease t ...


Key safety concerns with Denosumab ( Xgeva ) included in the Warnings and Precautions section of the existing product labeling involve the risks of osteonecrosis of the jaw ( ONJ ) and hypocalcemia. O ...


Bayer HealthCare has announced that the Food and Drug Administration ( FDA ) approved Stivarga ( Regorafenib ) tablets for the treatment of patients with metastatic colorectal cancer ( mCRC ) who have ...


The FDA ( Food and Drug Administration ) has approved Omontys ( Peginesatide ) to treat anemia in adult dialysis patients who have chronic kidney disease ( CKD ). Omontys is a new erythropoiesis-st ...


The European Commission ( EC ) has approved Eliquis ( Apixaban ) for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( NVAF ) with one or more risk f ...


The Food and Drug Administration ( FDA ) has approved Zyclara cream for the treatment of external genital and perianal warts ( EGW ) in patients 12 years of age and older. Zyclara cream’s clinical s ...


The European Commission has granted approval for the use of ALIMTA ( Pemetrexed for injection ) as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer ...


Amgen has informed physicians of important safety information for Prolia ( Denosumab ) and updates to the Prescribing Information.Prolia was originally approved by the FDA ( Food and Drug Administrati ...


The FDA ( Food and Drug Administration ) has updated healthcare professionals and the public on the potential drug interaction between Methylene Blue and serotonergic psychiatric medications. Most cas ...


The FDA ( Food and Drug Administration ) has updated information on the potential drug interaction between Linezolid ( Zyvox; in Europe: Zyvoxid ) and serotonergic psychiatric medications. Not all ser ...


The FDA ( Food and Drug Administration ) has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking ...


Eli Lilly and Boehringer Ingelheim have received marketing authorization from the European Commission for Linagliptin 5 mg film-coated tablets ( Trajenta ) for the treatment of adults with type 2 diab ...


The FDA ( Food and Drug Administration ) has asked manufacturers of prescription combination products that contain Acetaminophen ( Paracetamol ) to limit the amount of Acetaminophen to no more than 32 ...


Heart disease is a common cause of serious illness and death in smokers and is often a reason for people to stop smoking. Varenicline ( Chantix, Champix ) is one of the most commonly used drugs to hel ...


The FDA ( Food and Drug Administration ) has notified healthcare professionals that children born to mothers who take the anti-seizure medication Valproate sodium or related products ( Valproic acid a ...


The FDA ( Food and Drug Administration ) has granted marketing approval for Corifact, Factor XIII Concentrate ( human ), for the routine prophylactic treatment of congenital factor XIII ( FXIII ) defi ...


The PhVWP ( Pharmacovigilance Working Party ) carried out a review of fluoroquinolones with regard to the risk of QT interval prolongation, triggered by discrepancies noted for some products between t ...


The FDA ( U.S. Food and Drug Administration ) has approved Zyclara ( Imiquimod ), a new topical cream for actinic keratoses ( AK ) on the face or balding scalp. Clinical studies have proved Zyclara ...


Chronic obstructive pulmonary disease ( COPD ) is a leading cause of death worldwide, and the rate of COPD-related death is increasing. No current drug therapy alters the progressive decline in lung f ...


Tribenzor is a combination of Amlodipine, Hydrochlorothiazide, and Olmesartan medoxomil. Amlodipine is a calcium channel blocker. Amlodipine is a peripheral arterial vasodilator. Hydrochlorothiazide i ...


Sunovion Pharmaceuticals has announced that the FDA ( Food and Drug Administration ) has approved Latuda ( Lurasidone HCl ) tablets for the treatment of schizophrenia.Latuda is an oral, once-daily aty ...


FDA ( Food and Drug Administration ) has informed the public that results from a study conducted in France ( the Santé Adulte GH Enfant [ SAGhE ] study ) found that persons with certain kinds of short ...


The FDA ( Food and Drug Administration ) has approved Zortress ( Everolimus ) oral tablets for the prevention of organ rejection of kidney transplants in adult patients at low-to-moderate immunologic ...


Zometa ( Zoledronic acid ) is indicated for the prevention of skeletal related events ( pathological fractures, spinal compression, radiation or surgery to bone, or tumor-induced hypercalcemia ) in pa ...


The FDA ( Food and Drug Administration ) has approved Tribenzor ( Olmesartan medoxomil, Amlodipine, Hydrochlorothiazide ), a new three-in-one combination product taken once-daily for the treatment of ...


Investigational once-daily oral, direct factor Xa inhibitor, Edoxaban ( Lixiana ), was shown to be superior to Enoxaparin ( Lovenox ) in preventing venous thromboembolic ( VTE ) events in patients fol ...


On September 23, 2010, the FDA ( Food and Drug Administration ) announced that it would restrict access to Rosiglitazone ( Avandia ) through use of a Risk Evaluation and Mitigation Strategy, or REMS.U ...


Results from the phase III OPTIMAL study have shown that first-line Erlotinib ( Tarceva ) extended the time people with a distinct form of lung cancer lived without their disease getting worse ( progr ...


Preliminary results from a phase II study have shown that a combination of MetMAb, a unique monovalent antibody, with Erlotinib ( Tarceva ) nearly doubled the time people with high MET expressing non- ...