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The FDA ( U.S. Food and Drug Administration ) has approved Sarclisa ( Isatuximab ) in combination with Carfilzomib and Dexamethasone ( Kd ), for the treatment of adult patients with relapsed or refrac ...


The FDA ( U.S. Food and Drug Administration ) has approved supplemental New Drug Application ( sNDA ) for Lorbrena ( Lorlatinib ), a tyrosine kinase inhibitor ( TKI ), expanding the indication to incl ...


The U.S. Food and Drug Administration ( FDA ) has approved Ponvory ( Ponesimod ), a once-daily oral selective sphingosine-1-phosphate receptor 1 ( S1P1 ) modulator, to treat adults with relapsing form ...


The FDA ( U.S. Food and Drug Administration ) has approved Darzalex Faspro ( Daratumumab and Hyaluronidase-fihj ), a subcutaneous formulation of Daratumumab, in combination with Bortezomib, Cyclophos ...


The FDA ( U.S. Food and Drug Administration ) has approved the PD-1 inhibitor Libtayo ( Cemiplimab-rwlc; Cemiplimab ) for the first-line treatment of patients with advanced non-small cell lung cancer ...


The European Commission ( EC ) has granted marketing authorization for Tukysa ( Tucatinib ) in combination with Trastuzumab and Capecitabine for the treatment of adult patients with HER2-positive loca ...


The FDA ( US Food and Drug Administration ) has approved the following expanded indication for Entresto ( Sacubitril / Valsartan ): to reduce the risk of cardiovascular death and hospitalization for h ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Ukoniq ( Umbralisib ), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications ...


The FDA ( US Food and Drug Administration ) has approved Tepmetko ( Tepotinib ) for the treatment of adult patients with metastatic non-small cell lung cancer ( NSCLC ) harboring mesenchymal-epithelia ...


The European Commission has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high ( ...


The Food and Drug Administration ( FDA ) has approved Xalkori ( Crizotinib ) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell ...


The European Commission ( EC ) has approved Bavencio ( Avelumab ) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma ( U ...


The FDA ( U.S. Food and Drug Administration ) has approved Opdivo ( Nivolumab ) 240 mg injection for intravenous use every two weeks or 480 mg every four weeks in combination with CaboMetyx ( Cabozant ...


The European Commission ( EC ) has approved Rinvoq ( Upadacitinib, 15 mg ), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis ( PsA ) in adult ...


The European Commission ( EC ) has approved the extension of the indication of Invokana ( Canagliflozin ) to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in ...


The Food and Drug Administration ( FDA ) has extended the indication of Mylotarg ( Gemtuzumab ozogamicin ) for newly-diagnosed CD33-positive acute myeloid leukemia ( AML ) to include pediatric patient ...


The U.S. Food and Drug Administration ) FDA ) has granted accelerated approval to Tazverik ( Tazemetostat ) for the treatment of adults and pediatric patients aged 16 years and older with metastatic ...


The Food and Drug Administration ( FDA ) hasapproved Sarclisa ( Isatuximab-irfc; Isatuximab ) in combination with Pomalidomide and Dexamethasone for adult patients with multiple myeloma who have recei ...


The FDA ( U.S. Food and Drug Administration ) has approved Tukysa ( Tucatinib ) in combination with chemotherapy ( Capecitabine ) and Trastuzumab for the treatment of adult patients with advanced form ...


The European Commission has approved Sunosi ( Solriamfetol ) to improve wakefulness and reduce excessive daytime sleepiness ( EDS ) in adults with narcolepsy ( with or without cataplexy ) or obstructi ...


The Food and Drug Administration ( FDA ) has approved Margenza ( Margetuximab-cmkb; Margetuximab ) in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive b ...


Vyepti ( Eptinezumab-jjmr; Eptinezumab ) has been approved by the U.S. Food and Drug Administration ( FDA ) for the preventive treatment of migraine. The recommended dose is 100 mg every 3 months; so ...


The European Commission ( EC ) has approved Leqvio ( Inclisiran ) for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. This approval is based on the results of the ORION clin ...


The U.S. Food and Drug Administration ( FDA ) has approved Mycapssa ( Octreotide ) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment wit ...


The U.S. Food and Drug Administration ( FDA ) has approved Crysvita ( Burosumab-twza; Burosumab ) injection to treat patients age two and older with tumor-induced osteomalacia ( TIO ), a rare disease ...


The European Commission ( EC ) has approved Sarclisa ( Isatuximab ) in combination with Pomalidomide and Dexamethasone ( Pom-Dex ) for the treatment of adult patients with relapsed and refractory mult ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Rubraca ( Rucaparib ) for patients with deleterious BRCA mutation ( germline and/or somatic )-associated metastatic castrat ...


The FDA ( U.S. Food and Drug Administration ) has approved Onureg ( Azacitidine 300 mg tablets, CC-486 ) for the continued treatment of adult patients with acute myeloid leukemia ( AML ) who achieved ...


The European Commission ( EC ) has extended the marketing authorization of Alunbrig ( Brigatinib ) to include use as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-p ...


The Food and Drug Administration ( FDA ) has approved the first oral gonadotropin-releasing hormone ( GnRH ) receptor antagonist, Orgovyx ( Relugolix ) for adult patients with advanced prostate cancer ...


The FDA ( U.S. Food and Drug Administration ) has approved Tagrisso ( Osimertinib ) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of ge ...


The U.S. Food and Drug Administration ( FDA ) has approved Gavreto ( Pralsetinib ) for the treatment of adult and paediatric patients 12 years of age and older with advanced or metastatic rearranged d ...


The European Commission ( EC ) has granted conditional marketing authorization to Ayvakyt ( Avapritinib ) as a monotherapy for the treatment of adult patients with unresectable or metastatic gastroint ...


The European Commission has approved Zejula ( Niraparib ), an oral, once-daily PARP [ poly(ADP-ribose)polymerase ] inhibitor, as first-line monotherapy maintenance treatment for adult patients with ad ...


Calquence ( Acalabrutinib ), a next-generation selective Bruton’s tyrosine kinase ( BTK ) inhibitor, has been approved in the European Union ( EU ) for the treatment of adult patients with chronic lym ...


The U.S. Food and Drug Administration ( FDA ) has approved Ayvakit ( Avapritinib ) for the treatment of adults with unresectable ( unable to be removed with surgery ) or metastatic gastrointestinal st ...


The European Commission ( EC ) has approved Opdivo ( Nivolumab ) plus Yervoy ( Ipilimumab ) with two cycles of Platinum-based chemotherapy for the first-line treatment of adult patients with metastati ...


The European Commission has approved Tecentriq ( Atezolizumab ) in combination with Avastin ( Bevacizumab ) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma ( ...


Lynparza ( Olaparib ) has been approved in the European Union ( EU ) for patients with metastatic castration-resistant prostate cancer ( mCRPC ) with breast cancer susceptibility gene 1/2 ( BRCA1/2 ) ...


Forxiga ( Dapagliflozin ) has been approved in the European Union ( EU ) for the treatment of symptomatic chronic heart failure ( HF ) with reduced ejection fraction ( HFrEF ) in adults with and witho ...


Post-Finasteride syndrome ( PFS ) is a constellation of serious adverse side effects manifested in clinical symptoms that develop and persist in patients during and/or after discontinuing Finasteride ...


The FDA ( U.S. Food and Drug Administration ) has approved Alunbrig ( Brigatinib ) for adult patients with anaplastic lymphoma kinase-positive ( ALK+ ) metastatic non-small cell lung cancer ( NSCLC ) ...


The FDA ( U.S. Food and Drug Administration ) has provided full approval to Venclexta ( Venetoclax ) in combination with Azacitidine, or Decitabine, or low-dose Cytarabine ( LDAC ) for the treatment ...


Imfinzi ( Durvalumab ) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer ( ES-SCLC ) in combination with a choice of chemotherap ...


The U.S. Food and Drug Administration ( FDA ) has approved Opdivo ( Nivolumab ) 360 mg every three weeks plus Yervoy ( Ipilimumab ) 1 mg/kg every six weeks ( injections for intravenous use ) for the f ...


The Food and Drug Administration ( FDA ) has granted accelerated approval to Blenrep ( Belantamab mafodotin-blmf; Belantamab mafodotin ) for adult patients with relapsed or refractory multiple myeloma ...


The European Commission ( EC ) has granted marketing authorization for Jyseleca ( Filgotinib 200 mg and 100 mg tablets ), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate t ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Monjuvi ( Tafasitamab-cxix, Tafasitamab ), a CD19-directed cytolytic antibody, indicated in combination with Lenalidomide f ...


The FDA ( Food and Drug Administration ) has approved Gavreto ( Pralsetinib ) for the treatment of adults with metastatic rearranged during transfection ( RET ) fusion-positive non-small cell lung can ...


The Food and Drug Administration ( FDA ) has approved a new fixed-dose combination of Pertuzumab, Trastuzumab, and Hyaluronidase–zzxf ( Phesgo ) for subcutaneous injection for the following indicatio ...