Medicine Update by Xagena
FDA has approved Tibsovo in combination with Azacitidine for newly diagnosed acute myeloid leukemia
The Food and Drug Administration ( FDA ) has approved Tibsovo ( Ivosidenib ) in combination with Azacitidine for newly diagnosed acute myeloid leukemia ( AML ) with a susceptible IDH1 mutation, as det … read article
EMA: Tecvayli for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies
EMA ( European Medicines Agency ) has recommended a conditional marketing authorisation in the European Union ( EU ) for Tecvayli ( Teclistamab ) for the treatment of adult patients with relapsed and … read article
European Union: conditional approval for Carvykti, a multiple myeloma cell therapy
The European Commission ( EC ) has granted conditional marketing authorization ( CMA ) for Carvykti ( Ciltacabtagene autoleucel; Cilta-cel ) to treat relapsed and refractory multiple myeloma ( RRMM ) … read article
FDA has approved Enjaymo for the treatment for adults with cold agglutinin disease, a rare type of anemia
The FDA ( Food and Drug Administration ) has approved Enjaymo ( Sutimlimab-jome; Sutimlimab ) infusion to decrease the need for red blood cell transfusion due to hemolysis ( red blood cell destruction … read article
FDA has approved Leqvio, first-in-class small interfering RNA to lower cholesterol and keep it low with two doses a year
The US Food and Drug Administration ( FDA ) has approved Leqvio ( Inclisiran ), the first and only small interfering RNA ( siRNA ) therapy to lower low-density lipoprotein cholesterol ( LDL-C ) with t … read article
Update on results from MOVe-OUT Study of Molnupiravir, an investigational oral antiviral medicine, in at risk adults with mild-to-moderate COVID-19
Merck ( MSD ) and Ridgeback Biotherapeutics have provided an update on the MOVe-OUT study of Molnupiravir ( MK-4482, EIDD-2801 ), an investigational oral antiviral medicine for COVID-19. Data are no … read article
Neoadjuvant Nivolumab plus chemotherapy has significantly improved event-free survival in patients with resectable non-small cell lung cancer in CheckMate -816
The phase 3 CheckMate -816 trial has met the primary endpoint of improved event-free survival ( EFS ) in patients with resectable stage IB to IIIA non-small cell lung cancer ( NSCLC ). In a prespe … read article
Chronic heart failure in adult patients with reduced ejection fraction : Verquvo approved in the European Union
The European Commission ( EC ) has granted marketing authorization in the European Union ( EU ) for soluble guanylate cyclase ( sGC ) stimulator Verquvo ( Vericiguat ). In the EU, Verquvo ( 2.5 mg, … read article
Zynlonta for large B-cell lymphoma, FDA has granted accelerated approval
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, … read article
Kerendia to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes – Approved by FDA
FDA has approved Kerendia ( Finerenone ) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in … read article
FDA has approved Lumakras, the first and only targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
The U.S. Food and Drug Administration ( FDA ) has approved Lumakras ( Sotorasib ) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer ( … read article
Darzalex Faspro for newly diagnosed light chain amyloidosis, accelerated approval by FDA
The FDA ( Food and Drug Administration ) has granted accelerated approval to Darzalex Faspro ( Daratumumab plus hyaluronidase ) in combination with Bortezomib, Cyclophosphamide and Dexamethasone for n … read article
FDA has approved Libtayo for non-small cell lung cancer with high PD-L1 expression
The Food and Drug Administration ( FDA ) has approved Libtayo ( Cemiplimab-rwlc, Cemiplimab ) for the first-line treatment of patients with advanced non-small cell lung cancer ( NSCLC ) ( locally adva … read article
European Union: Keytruda, an anti-PD-1 therapy, approved for metastatic microsatellite instability-high colorectal cancer patients
The European Commission ( EC ) has approved Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability … read article
FDA has approved Verquvo for patients with symptomatic chronic heart failure
The U.S. Food and Drug Administration ( FDA ) has approved soluble guanylate cyclase ( sGC ) stimulator Vericiguat under the brand name Verquvo. Vericiguat 2.5 mg, 5 mg, and 10 mg is indicated to re … read article
