Drugs Xagena
The FDA ( U.S. Food and Drug Administration ) has approved Poteligeo ( Mogamulizumab-kpkc ) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoi ...
The European Commission has granted marketing authorisation for Tagrisso ( Osimertinib ), a third-generation, irreversible EGFR-TKI, as monotherapy for the 1st-line treatment of adult patients with lo ...
Early data from two clinical trials have shown reduced survival with Keytruda ( Pembrolizumab ) and Tecentriq ( Atezolizumab ) when used as first-line treatments for urothelial cancer ( cancer of the ...
The European Commission has approved a label update for the use of once-daily Relvar Ellipta ( Fluticasone furoate / Vilanterol, FF/VI ), an inhaled corticosteroid ( ICS ) / long-acting beta2-agonist ...
The European Commission ( EC ) has approved Cabometyx ( Cabozantinib ) 20, 40, 60 mg for the first-line treatment of adults with intermediate- or poor- risk advanced renal cell carcinoma ( aRCC ). ...
The Food and Drug Administration ( FDA ) has approved Osimertinib ( Tagrisso ) for the first-line treatment of patients with metastatic non-small cell lung cancer ( NSCLC ) whose tumors have epidermal ...
The European Medicines Agency ( EMA ) has approved Lynparza ( Olaparib ) tablets ( 300mg twice daily ) for use as a maintenance therapy for patients with Platinum-sensitive relapsed high-grade, epithe ...
The FDA ( US Food and Drug Administration ) has approved Kisqali ( Ribociclib ) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative ( HR+/HER2- ) advanced or me ...
The U.S. Food and Drug Administration ( FDA ) has approved Tafinlar ( Dabrafenib ) and ( Trametinib ), administered together, for the treatment of anaplastic thyroid cancer ( ATC ) that cannot be remo ...
The European Commission has granted marketing authorisation for Lokelma ( formerly ZS-9, sodium Zirconium cyclosilicate ) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious c ...
The FDA ( U.S. Food and Drug Administration ) has approved Biktarvy ( Bictegravir 50mg / Emtricitabine 200mg / Tenofovir alafenamide 25mg, BIC/FTC/TAF ), a once-daily single tablet regimen ( STR ) for ...
The FDA ( U.S. Food and Drug Administration ) has approved Lutathera ( Lutetium Lu 177 dotatate ) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastr ...
The FDA ( U.S. Food and Drug Administration ) has approved Imfinzi ( Durvalumab ) for the treatment of patients with stage III non-small cell lung cancer ( NSCLC ) whose tumors are not able to be surg ...
The FDA ( U.S. Food and Drug Administration ) has approved Erleada ( Apalutamide ) for the treatment of patients with prostate cancer that has not spread ( non-metastatic ), but that continues to grow ...
The FDA ( U.S. Food and Drug Administration ) has approved Imfinzi ( Durvalumab ) for the treatment of patients with stage III non-small cell lung cancer ( NSCLC ) whose tumors are not able to be surg ...
European Commission ( EC ) has granted marketing authorisation for Ocrevus ( Ocrelizumab ) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and fo ...
The U.S. Food and Drug Administration ( FDA ) has approved Mylotarg ( Gemtuzumab ozogamicin ) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 anti ...
The U.S. Food and Drug Administration ( FDA ) has expanded the approved use of Nucala ( Mepolizumab ) to treat adult patients with eosinophilic granulomatosis with polyangiitis ( EGPA ), a rare autoim ...
On August 1, 2017, the FDA ( U.S. Food and Drug Administration ) has granted regular approval to Idhifa ( Enasidenib ) for the treatment of adult patients with relapsed or refractory acute myeloid leu ...
The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Aliqopa ( Copanlisib ) for the treatment of adult patients with relapsed follicular lymphoma who have received at leas ...
The FDA ( U.S. Food and Drug Administration ) has expanded the approved use of Dysport ( AbobotulinumtoxinA ) for injection for the treatment of spasticity in adults, based on its supplemental Biologi ...
The FDA ( U.S. Food and Drug Administration ) has approved Endari ( L-Glutamine oral powder ) for patients age five years and older with sickle cell disease to reduce severe complications associated w ...
The European Commission ( EC ) has approved Fotivda ( Tivozanib ) for the treatment of adult patients with advanced renal cell carcinoma ( RCC ) in the European Union plus Norway and Iceland. Tivoza ...
The FDA ( U.S. Food and Drug Administration ) has approved Nerlynx ( Neratinib ) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cance ...
The European Commission ( EC ) has approved Alecensa ( Alectinib ), a second-generation ALK inhibitor, for the frontline treatment of patients with ALK-positive metastatic non–small cell lung cancer ( ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Calquence ( Acalabrutinib ) for the treatment of adults with mantle cell lymphoma who have received at least one prior ther ...
The European Commission ( EC ) has granted marketing authorization for Stivarga ( Regorafenib ) for the treatment of adult patients with hepatocellular carcinoma ( HCC ) who have been previously treat ...
The US Food and Drug Administration ( FDA ) has approved Kymriah ( Tisagenlecleucel ) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell ( CAR-T ) therapy ...
In non-small cell lung cancer ( NSCLC ) that has already formed metastases, the suitable treatment depends, among other factors, on the genes that are activated in the tumour cells and whether mutatio ...
The European Commission ( EC ) has granted marketing authorization for Vosevi ( Sofosbuvir 400mg / Velpatasvir 100mg / Voxilaprevir 100mg ), as a once-daily single tablet regimen for the treatment of ...
The European Commission ( EC ) has approved Opdivo ( Nivolumab ) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma ( mUC ) in adults after failure of prior Platinum ...
The FDA ( U.S. Food and Drug Administration ) has expanded the approved use of subcutaneous Actemra ( Tocilizumab ) to treat adults with giant cell arteritis. This new indication provides the first ...
The FDA ( US Food and Drug Administration ) has granted accelerated approval to Imfinzi ( Durvalumab ). Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelia ...
The European Commission ( EC ) has granted Conditional Marketing Authorisation for Natpar ( rhPTH [ 1-84 ] ), the first recombinant human protein with the full length 84-amino acid sequence of endogen ...
The FDA ( Food and Drug Administration ) has granted full approval for Tagrisso ( Osimertinib ) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor ...
The US Food and Drug Administration ( FDA ) has granted accelerated approval to Tecentriq ( Atezolizumab ) for the treatment of people with locally advanced or metastatic urothelial carcinoma ( mUC ) ...
The U.S. Food and Drug Administration ( FDA ) has approved Ocrevus ( Ocrelizumab ) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority ...
The FDA ( U.S. Food and Drug Administration ) has approved Odactra, the first allergen extract to be administered under the tongue ( sublingually ) to treat house dust mite (HDM)-induced nasal inflamm ...
The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), the anti-PD-1 ( programmed death receptor-1 ) therapy, for the treatment of adult and pediatric patients with ref ...
The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Bavencio ( Avelumab ) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cel ...
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 U.S. Food and Drug Administration ( FDA ) has approved Nuplazid ( Pimavanserin ) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by som ...
