Xagena.net - Update in Medicine

Augtyro based on Repotrectinib for ROS1-positive non-small cell lung cancer. Approval by FDA

The Food and Drug Administration ( FDA ) has approved Augtyro ( Repotrectinib ) for locally advanced or metastatic ROS1-positive non-small cell lung cancer ( NSCLC ). This is the first FDA approval t ... read article

Zynyz based on Retifanlimab for metastatic or recurrent locally advanced Merkel cell carcinoma. FDA has granted accelerated approval

The Food and Drug Administration FDA ) has granted accelerated approval to Zynyz ( Retifanlimab-dlwr; Retifanlimab ) for adult patients with metastatic or recurrent locally advanced Merkel cell carcin ... read article

Patients with atrial fibrillation at risk for stroke: OCEANIC-AF study stopped early due to inferior efficacy of Asundexian versus Apixaban

OCEANIC-AF, a phase III study investigating Asundexian compared to Apixaban, a direct oral anticoagulant, in patients with atrial fibrillation at risk for stroke is being stopped early. This decisio ... read article

Tibsovo based on Ivosidenib for myelodysplastic syndromes. FDA has approved

The Food and Drug Administration ( FDA ) has approved Tibsovo ( Ivosidenib ) for adult patients with relapsed or refractory myelodysplastic syndromes ( MDS ) with a susceptible isocitrate dehydrogenas ... read article

Talzenna with Enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer. FDA approved

The Food and Drug Administration ( FDA ) has approved Talzenna ( Talazoparib ) with Enzalutamide for homologous recombination repair ( HRR ) gene-mutated metastatic castration-resistant prostate cance ... read article

Elrexfio based on Elranatamab for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. FDA granted accelerated approval

The Food and Drug Administration ( FDA ) has granted accelerated approval to Elrexfio ( Elranatamab-bcmm; Elranatamab ), a bispecific B-cell maturation antigen ( BCMA )-directed CD3 T-cell engager, fo ... read article

Litfulo for treatment of severe alopecia in individuals aged 12 years and older. FDA approved

The FDA ( Food and Drug Administration ) has approved Litfulo ( Ritlecitinib ), a once-daily oral treatment, for the treatment of severe alopecia in individuals aged 12 years and older. Ritlecitini ... read article

European Commission has revoked the conditional marketing authorization for Adakveo in vaso-occlusive crises in patients with sickle cell disease

The European Medicine Agency’s ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has recommended revoking the conditional marketing authorization ( MA ) for Crizanlizumab ( Adakveo ). ... read article

Claudin-18.2 targeting by Zolbetuximab in CLDN18.2-positive, HER2-negative advanced gastric or gastro-oesophageal junction cancer: results of SPOTLIGHT in perspective

The advances in biomarker-based targeted treatments have been slow for patients with stage IV gastro-oesophageal adenocarcinoma, with median overall survival for patients with HER2-negative disease n ... read article

FDA has granted accelerated approval to Padcev with Pembrolizumab for locally advanced or metastatic urothelial carcinoma

The Food and Drug Administration ( FDA ) has granted accelerated approval to Padcev ( Enfortumab vedotin-ejfv; Enfortumab vedotin ) with Pembrolizumab ( Keytruda ) for patients with locally advanced o ... read article

Oluminat, first systemic treatment for alopecia areata, approved by FDA

The U.S. Food and Drug Administration ( FDA ) has approved Olumiant ( Baricitinib ) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness a ... read article

Libtayo in combination with chemotherapy approved by the FDA as first-line treatment for advanced non-small cell lung cancer irrespective of PD-L1 expression

The U.S. Food and Drug Administration ( FDA ) has approved the PD-1 inhibitor Libtayo ( Cemiplimab-rwlc; Cemiplimab ) in combination with Platinum-based chemotherapy for the first-line treatment of ad ... read article

Tzield, the first drug that can delay onset of type 1 diabetes. FDA has approved

The U.S. Food and Drug Administration ( FDA ) has approved Tzield ( Teplizumab-mzwv; Teplizumab ) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and o ... read article

FDA has approved Nubeqa tablets for metastatic hormone-sensitive prostate cancer

The Food and Drug Administration ( FDA ) has approved Darolutamide ( Nubeqa ) tablets in combination with Docetaxel for adult patients with metastatic hormone-sensitive prostate cancer ( mHSPC ). E ... read article

Tofersen data have shown benefits in rare, genetic form of amyotrophic lateral sclerosis, SOD1-ALS

The New England Journal of Medicine ( NEJM ) has published detailed results from the phase 3 VALOR study and the combined analysis of VALOR and its open label extension ( OLE ) study evaluating Tofers ... read article