Drugs Xagena
The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Keytruda ( Pembrolizumab ) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphom ...
The FDA ( U.S. Food and Drug Administration ) has approved Xadago ( Safinamide ) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking Levodopa / Carbidopa and ...
The CDK 4/6 inhibitor Ribociclib ( Kisqali ) has been approved by the FDA ( Food and Drug Administration ) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopau ...
Rhofade ( Oxymetazoline hydrochloride ) cream has been approved by the U.S. Food and Drug Administration ( FDA ) for the topical treatment of persistent facial erythema associated with rosacea in adul ...
The FDA ( U.S. Food and Drug Administration ) has approved Siliq ( Brodalumab ) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended for ...
There is general consensus about the large and persuasive body of evidence that statins are effective and safe in reducing cardiovascular morbidity and mortality in secondary and primary prevention as ...
The European Commission ( EC ) has approved Revlimid ( Lenalidomide ) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous ...
The European Commission ( EC ) has granted marketing authorisation for Olumiant ( Baricitinib ) 4 mg and 2 mg film-coated tablets in Europe for the treatment of moderate-to-severe active rheumatoid ar ...
The FDA ( Food and Drug Administration ) has approved Opdivo ( Nivolumab ) injection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma ( mUC ) ...
The FDA ( Food and Drug Administration ) has approved a new indication for Jardiance ( Empagliflozin ) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established ...
The European Medicines Agency's ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for the use of Alecensa ( Alectinib ) for the treatment of adult patients ...
The Food and Drug Administration ( FDA ) has approved Keytruda ( Pembrolizumab), an anti-PD-1 ( programmed death receptor-1 ) therapy, for the first-line treatment of patients with metastatic non-smal ...
The FDA ( Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) for the treatment of people with metastatic non-small cell lung cancer ( NSCLC ) who have disease progression during or ...
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending marketing authorisation in the European Union for the u ...
The U.S. Food and Drug Administration ( FDA ) has approved once-daily Yosprala, the only prescription fixed-dose combination of Aspirin, an anti-platelet agent, and Omeprazole, a proton pump inhibitor ...
The European Commission ( EC ) has issued a marketing authorisation for Kisplyx ( Lenvatinib ) in combination with Everolimus ( Afinitor ) for the treatment of adult patients with advanced renal cell ...
Two anti-proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) monoclonal antibodies, Alirocumab and Evolocumab, have been approved for the treatment of hypercholesterolaemia in certain patients. ...
The European Commission has granted marketing authorization for Epclusa ( Sofosbuvir 400 mg / Velpatasvir 100 mg ), the first pan-genotypic, single tablet regimen for the treatment of adults with geno ...
The FDA ( Food and Drug Administration ) has granted a Breakthrough Therapy Designation to the immunotherapy Darzalex ( Daratumumab ) in combination with Lenalidomide ( Revlimid ), an immunomodulatory ...
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for the medicinal product Truberzi, intended for the treatment of adults with irritable bowel syndrome with d ...
The Committee for Medicinal Products for Human Use ( CHMP ), the scientific committee of the European Medicines Agency ( EMA ) has provided a positive opinion for Cabometyx ( Cabozantinib ) 20, 40, 6 ...
The European Commission ( EC ) has approved Keytruda ( Pembrolizumab ), the anti-PD-1 therapy, at a dose of 2 mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell l ...
The Food and Drug Administration ( FDA ) has approved Keytruda ( Pembrolizumab ), the anti-PD-1 ( programmed death receptor-1 ) therapy, at a fixed dose of 200 mg every three weeks, for the treatment ...
Roche has announced that the European Medicines Agency ( EMA ) has validated the company’s Marketing Authorisation Application ( MAA ) of Ocrevus ( Ocrelizumab ) for the treatment of relapsing multipl ...
The FDA ( Food and Drug Administration ) Advisory Committee has voted 12-11 that substantial evidence exists to establish that Jardiance ( Empagliflozin ) reduces cardiovascular death in adults with t ...
The FDA ( Food and Drug Administration ) has approved Zinbryta ( Daclizumab ) for the treatment of adults with relapsing forms of multiple sclerosis. Zinbryta is a long-acting injection that is self- ...
The Antimicrobial Drugs Advisory Committee of the FDA ( Food and Drug Administration ) has discussed Zinplava ( Bezlotoxumab ), an investigational agent for prevention of Clostridium difficile ( C. d ...
The Committee of Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending approval of a variation to the marketing authorization o ...
The FDA ( Food and Drug Administration ) has approved Cabometyx ( Cabozantinib ) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The ...
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has granted a positive opinion for Humira ( Adalimumab ) for the treatment of non-infectious interm ...
The FDA ( U.S. Food and Drug Administration ) has granted Orphan Drug Designation for MYK-461 for treatment of symptomatic obstructive hypertrophic cardiomyopathy ( oHCM ), a subset of hypertrophic ca ...
The FDA ( Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class ( ...
The U.S. Food and Drug Administration ( FDA ) has approved an additional indication for Lenvima ( Lenvatinib mesylate ) in combination with Everolimus ( Afinitor ) for the treatment of patients with a ...
The European Commission ( EC ) has approved Alprolix ( rFIXFc ) for the treatment of haemophilia B in all 28 European Union ( EU ) member states and maintained its orphan designation. Alprolix is th ...
The European Commission has approved Empliciti ( Elotuzumab ) for the treatment of multiple myeloma as combination therapy with Revlimid ( Lenalidomide ) and Dexamethasone in patients who have receive ...
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion, recommending broadening the existing marketing authorisation for Im ...
The Committee for Medicinal Products for Human Use ( CHMP ) of European Medicine Agency ( EMA ) has adopted a positive opinion for Gazyvaro ( Obinutuzumab; Gazyva in U.S. ) in combination with Bendam ...
The fixed-dose combination of Sacubitril and Valsartan ( Entresto ) has been approved for adults with symptomatic chronic heart failure with reduced ejection fraction. The German Institute for Quali ...
The FDA ( Food and Drug Administration ) has approved Idelvion, coagulation factor IX ( recombinant ), albumin fusion protein, for use in children and adults with hemophilia B. Idelvion is the first ...
The FDA ( Food and Drug Administration ) has granted Priority Review for Atezolizumab ( anti-PD-L1; MPDL3280A ) for the treatment of people with locally advanced or metastatic urothelial carcinoma ( m ...
The FDA ( Food and Drug Administration ) has approved Imbruvica ( Ibrutinib ) as a first-line treatment for patients with chronic lymphocytic leukemia ( CLL ). The approval is based on data from the ...
The FDA ( Food and Drug Administration ) has approved Briviact ( Brivaracetam ) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epil ...
The FDA ( Food and Drug Administration ) has granted Breakthrough Therapy designation to PKC412 ( Midostaurin ). Midostaurin is an investigational treatment for adults with newly-diagnosed acute mye ...
The FDA ( Food and Drug Administration ) has approved additional indications for Harvoni ( Ledipasvir / Sofosbuvir ) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in c ...
The European Commission ( EC ) has approved Briviact ( Brivaracetam ) as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization ( spreading to both s ...
The phase 3 GAUSS-3 ( Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 ) trial evaluating Evolocumab ( Repatha ) in patients with high cholesterol who cannot tol ...
The FDA ( Food and Drug Administration ) has accepted the New Drug Application ( NDA ) and granted Priority Review for Venetoclax for the treatment of people with chronic lymphocytic leukemia ( CLL ) ...
The US Food and Drug Administration ( FDA ) has approved Biologics License Application ( BLA ) for Nucala ( Mepolizumab ) as an add-on maintenance treatment of patients with severe asthma aged 12 year ...
Targin ( Targinact, Targiniq ), a fixed combination of prolonged-release Oxycodone / Naloxone, has received a positive European Commission ( EC ) decision for a new indication, as a second line sympto ...
Strensiq, an innovative enzyme replacement therapy ( ERT ), is the first therapy approved in the U.S. for the treatment of patients with HPP, a genetic, chronic, and progressive ultra-rare metabolic ...
