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The FDA ( US Food and Drug Administration ) has approved Kesimpta ( Ofatumumab, formerly OMB157 ) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis ( RMS ...


Givlaari is a medicine for treating acute hepatic porphyria in patients aged 12 years or over. Acute hepatic porphyria is a rare genetic condition in which the liver cannot properly produce a substanc ...


The European Commission has granted conditional marketing authorisation for Blenrep ( Belantamab mafodotin ) as monotherapy for the treatment of multiple myeloma in adult patients who have received at ...


The U.S. Food and Drug Administration ( FDA ) has approved Darzalex ( Daratumumab ) in combination with Kyprolis ( Carfilzomib ) and Dexamethasone ( DKd ) for the treatment of adult patients with rela ...


The European Commission has granted conditional marketing authorisation for Rozlytrek ( Entrectinib ) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours ex ...


The U.S. Food and Drug Administration ( FDA ) has approved Tepezza ( Teprotumumab-trbw; Teprotumumab ) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatt ...


The Food and Drug Administration ( FDA ) has approved an oral combination of Decitabine and Cedazuridine ( Inqovi ) for adult patients with myelodysplastic syndromes ( MDS ) including the following: p ...


The Food and Drug Administration ( FDA ) has granted accelerated approval to Tazverik ( Tazemetostat ), an EZH2 inhibitor, for adult patients with relapsed or refractory ( R/R ) follicular lymphoma ( ...


The European Commission ( EC ) has approved Reblozyl ( Luspatercept ) for the treatment of: a) adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodys ...


The FDA ( U.S. Food and Drug Administration ) has approved Koselugo ( Selumetinib ) for the treatment of pediatric patients, 2 years of age and older, with neurofibromatosis type 1 ( NF1 ), a genetic ...


The FDA ( U.S. Food and Drug Administration ) has approved Tecentriq ( Atezolizumab ) in combination with Avastin ( Bevacizumab ) for the treatment of people with unresectable or metastatic hepatocell ...


The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metas ...


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 ...