Drugs Xagena
The FDA ( US Food and Drug Administration ) has approved Cosentyx ( Secukinumab ) for the treatment of active non-radiographic axial spondyloarthritis ( nr-axSpA ), confirming Cosentyx efficacy in add ...
Opdivo ( Nivolumab ) was approved by the U.S. Food and Drug Administration ( FDA ) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma ...
The U.S. Food and Drug Administration ( FDA ) has approved Retevmo ( Selpercatinib ) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of ...
The FDA ( US Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) as a first-line treatment for adults with metastatic non-small cell lung cancer ( NSCLC ) whose tumours have high PD ...
The FDA ( U.S. Food and Drug Administration ) has approved Tabrecta ( Capmatinib ) for the treatment of adult patients with non-small cell lung cancer ( NSCLC ) that has spread to other parts of the b ...
Opdivo ( Nivolumab ) 3 mg/kg plus Yervoy ( Ipilimumab ) 1 mg/kg ( injections for intravenous use ) was approved by the U.S. Food and Drug Administration ( FDA ) for the first-line treatment of adult p ...
The FDA ( U.S. Food and Drug Administration ) has approved Qinlock ( Ripretinib ) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal t ...
Imfinzi ( Durvalumab ) has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer ( ES-SCLC ) in combination with standard-of-care ( SoC ) chem ...
Opdivo ( Nivolumab ) 1 mg/kg plus Yervoy ( Ipilimumab ) 3 mg/kg ( injections for intravenous use ) was approved by the U.S. Food and Drug Administration ( FDA ) to treat hepatocellular carcinoma ( HCC ...
The FDA ( U.S. Food and Drug Administration ) has approved Isturisa ( Osilodrostat ) oral tablets for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone ...
The European Commission has approved Venclyxto ( Venetoclax ) in combination with Gazyvaro ( Obinutuzumab ) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia ...
The European Commission ( EC ) has granted marketing authorisation for the expanded use of Erleada ( Apalutamide ) to include the treatment of adult men with metastatic hormone-sensitive prostate canc ...
The European Commission ( EC ) has approved Mayzent ( Siponimod ) for the treatment of adult patients with secondary progressive multiple sclerosis ( SPMS ) with active disease evidenced by relapses o ...
The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin ( BCG )-unrespon ...
The European Commission has granted conditional marketing authorisation for Polivy ( Polatuzumab vedotin ), in combination with Bendamustine plus MabThera ( Rituximab ) ( BR ), for the treatment of ad ...
The FDA ( U.S. Food and Drug Administration ) has approved Ayvakit ( Avapritinib ) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor ( GIST ), a type of tumor ...
The U.S. Food and Drug Administration ( FDA ) has approved Ubrelvy ( Ubrogepant ) tablets for the acute treatment of migraine with or without aura ( a sensory phenomenon or visual disturbance ) in adu ...
The Food and Drug Administration ( FDA ) has approved Keytruda ( Pembrolizumab ) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinom ...
Waylivra ( Volanesorsen ) has received conditional marketing authorization from the European Commission ( EC ) as an adjunct to diet in adult patients with genetically confirmed familial chylomicronem ...
The FDA ( Food and Drug Administration ) has approved Fragmin ( Dalteparin sodium ) injection to reduce the recurrence of symptomatic venous thromboembolism ( VTE ) among children aged at least 1 mont ...
The FDA ( US Food and Drug Administration ) has approved a supplemental New Drug Application ( sNDA) for Xofluza ( Baloxavir marboxil ) for the treatment of acute, uncomplicated influenza, or flu, in ...
The FDA ( U.S. Food and Drug Administration ) has approved Xcopri ( Cenobamate tablets ) to treat partial-onset seizures in adults. A seizure is a usually short episode of abnormal electrical activ ...
Safinamide mesilate, discovered and developed by Newron Pharmaceuticals ( Milan, Italy ), is a selective monoamine oxidase B ( MAO-B ) inhibitor, which reduces the degradation of excreted dopamine, he ...
European Commission ( EC ) has approved Spravato ( Esketamine ) nasal spray, in combination with a selective serotonin reuptake inhibitor ( SSRI ) or serotonin and norepinephrine reuptake inhibitor ( ...
The FDA ( U.S. Food and Drug Administration ) has approved XCopri ( Cenobamate tablets ) to treat partial-onset seizures in adults. A seizure is a usually short episode of abnormal electrical activ ...
The European Commission has approved Keytruda ( Pembrolizumab ) as a monotherapy or in combination with Platinum and 5-Fluorouracil ( 5-FU ) chemotherapy for the frontline treatment of patients with m ...
The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Oxbryta ( Voxelotor ) for the treatment of sickle cell disease ( SCD ) in adults and pediatric patients 12 years of ag ...
The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Brukinsa ( Zanubrutinib ) capsules for the treatment of adult patients with mantle cell lymphoma who have received at ...
Tthe US Food and Drug Administration ( FDA ) has approved Calquence ( Acalabrutinib ) for adult patients with chronic lymphocytic leukaemia ( CLL ) or small lymphocytic lymphoma ( SLL ). The US appr ...
The FDA ( US Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) in combination with chemotherapy ( Abraxane [ Paclitaxel protein-bound; nab-Paclitaxel ] and Carboplatin ) for the i ...
The European Commission ( EC ) has approved Keytruda , an anti-PD-1 therapy, as monotherapy or in combination with Platinum and 5-Fluorouracil ( 5-FU ) chemotherapy, for the first-line treatment of pa ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Polatuzumab vedotin-piiq ( Polivy; Polatuzumab vedotin ), a CD79b-directed antibody-drug conjugate indicated in combination ...
The FDA ( U.S. Food and Drug Administration ) has granted approval to Reblozyl ( Luspatercept–aamt; Luspatercept ) for the treatment of anemia in adult patients with beta-thalassemia who require regul ...
The FDA ( U.S. Food and Drug Administration ) has approved Rybelsus ( Semaglutide ) oral tablets to improve control of blood glucose in adult patients with type 2 diabetes, along with diet and exercis ...
The European Commission ( EC ) has approved Bavencio ( Avelumab ) in combination with Axitinib ( Inlyta ) for the first-line treatment of adult patients with advanced renal cell carcinoma ( RCC ). ...
The European Commission has approved Xeomin ( IncobotulinumtoxinA ) for the symptomatic treatment of chronic sialorrhea due to neurological disorders in adult patients. Xeomin is the first and only n ...
The European Commission ( EC ) has approved the oral once-daily therapy Xospata ( Gilteritinib ) as a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia ...
The FDA ( U.S. Food and Drug Administration ) has approved Sunosi ( Solriamfetol ) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive ...
The FDA ( U.S. Food and Drug Administration ) has approved Reyvow ( Lasmiditan ) tablets for the acute treatment of migraine with or without aura ( a sensory phenomenon or visual disturbance ) in adul ...
The FDA ( U.S. Food and Drug Administration ) has approved Ofev ( Nintedanib ) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with syste ...
The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir ) tablets for an eight-week duration for the treatment of adults and children ages 12 ...
The European Commission has granted marketing authorization in the European Union ( EU ) for the precision oncology treatment Vitrakvi ( Larotrectinib ). The drug is indicated for the treatment of a ...
The European Commission ( EC ) has granted marketing authorisation for Erleada ( Apalutamide ), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastat ...
The FDA ( U.S. Food and Drug Administration ) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence ( OCE ). Project Orbis provides a framework for concurrent submissio ...
The European Commission ( EC ) has approved Empliciti ( Elotuzumab ) plus Pomalidomide and low-dose Dexamethasone ( EPd ) for the treatment of adult patients with relapsed and refractory multiple myel ...
The Food and Drug Administration ( FDA ) has approved Nubeqa ( Darolutamide ) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS, a multicenter, double-blind, pla ...
The European Commission has approved Tecentriq ( Atezolizumab ) plus chemotherapy ( Abraxane [ Paclitaxel protein-bound particles for injectable suspension ( albumin-bound ); nab-Paclitaxel ] ) for th ...
The FDA ( Food and Drug Administration ) has granted accelerated approval to Xpovio ( Selinexor ) in combination with Dexamethasone for adult patients with relapsed or refractory multiple myeloma ( RR ...
The FDA ( Food and Drug Administration ) has approved Inrebic ( Fedratinib ) for adults with intermediate-2 or high-risk primary or secondary ( post-polycythemia vera or post-essential thrombocythemia ...
The FDA ( U.S. Food and Drug Administration ) has approved Rinvoq ( Upadacitinib ), a 15 mg, once-daily oral Janus kinase ( JAK ) inhibitor, for the treatment of adults with moderately to severely act ...
