Drugs Xagena
The U.S. Food and Drug Administration ( FDA ) has approved Zynlonta ( Loncastuximab tesirine-lpyl; Loncastuximab tesirine ) for the treatment of adult patients with relapsed or refractory ( r/r ) larg ...
The U.S. Food and Drug Administration ( FDA ) has approved Pradaxa ( Dabigatran etexilate ) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism directly after ...
The U.S. Food and Drug Administration ( FDA ) has approved Lumakras ( Sotorasib ) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic ...
Tagrisso ( Osimertinib ), an irreversible epidermal growth factor receptor tyrosine kinase inhibitor ( EGFR TKI ), has been approved in the European Union ( EU ) for the adjuvant treatment of adult pa ...
The Food and Drug Administration ( FDA ) has granted accelerated approval to Zynlonta ( Loncastuximab tesirine-lpyl; Loncastuximab tesirine ), a CD19-directed antibody and alkylating agent conjugate, ...
The European Commission ( EC ) has approved Sarclisa ( Isatuximab ) in combination with Carfilzomib and Dexamethasone ( Kd ) for the treatment of adult patients with relapsed multiple myeloma who have ...
Farxiga ( Dapagliflozin ), a sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate ( eGFR ) decline, end- ...
European Commission has approved Tecentriq ( Atezolizumab ) as a first-line treatment for adults with metastatic non-small cell lung cancer ( NSCLC ) whose tumours have high PD-L1 expression, with no ...
The FDA ( US Food and Drug Administration ) has approved Jemperli ( Dostarlimab-gxly; Dostarlimab ), a programmed death receptor-1 ( PD-1 ) blocking antibody. Dostarlimab is indicated for the treatmen ...
The FDA ( Food and Drug Administration ) has approved Enhertu ( fam-Trastuzumab Deruxtecan-nxki; fam-Trastuzumab Deruxtecan ) for adult patients with locally advanced or metastatic HER2-positive gastr ...
The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval of Trodelvy ( Sacituzumab govitecan-hziy; Sacituzumab govitecan ) for use in adult patients with locally advanced or meta ...
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 ) ...
