Page 31 - Priority Review News Today

— FRUZAQLA is the first targeted therapy approved in the U.S. for metastatic colorectal cancer regardless of biomarker status or prior types of therapies...

Takeda announced that the U.S. Food and Drug Administration has approved FRUZAQLA? , an oral targeted therapy for adults with metastatic colorectal cancer who have been previously treated with...

− FRUZAQLA is the First Targeted Therapy Approved for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status or Prior Types of Therapies in More Than a Decade− FRUZAQLA Plus Best Supportive Care Demonstrated Significant Improvements in Overall Survival, with Corresponding Improvements in Progression Free...

Takeda TSE4502NYSETAK today announced that the U.S. Food and Drug Administration FDA has approved FRUZAQLA fruquintinib an oral targeted therapy for adults with metastatic colorectal cancer mCRC who have been previously treated with fluoropyrimidine oxaliplatin and irinotecanbased chemotherapy an antiVEGF therapy and if RAS wildtype and medically appropriate an antiEGFR therapy.

Company announcement - No. 38 / 2023 Zealand Pharma Announces Financial Results for the First Nine Months of 2023 Strong progress across obesity pipeline, first PDUFA date for dasiglucagon in CHI in 2023 and solid financial position Boehringer Ingelheim advances GCGR/GLP-1R dual agonist survodutide (BI456906) into Phase 3 trials in obesityZealand presents amylin analog ZP8396 6-week trial results at ObesityWeek and initiates GLP-1R/GLP-2R dual agonist dapiglutide 13-week dose titration trialZeal

(RTTNews) - Takeda (TAK) said that the U.S. Food and Drug Administration has approved Fruzaqla (fruquintinib), an oral targeted therapy for adults...

The FDA has accepted for Priority Review the NDA for tovorafenib as monotherapy in relapsed or progressive pediatric low-grade glioma.

The FDA has granted priority review to the supplemental biologics license application seeking approval to expand the indication of lisocabtagene maraleucel to include patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a BTK inhibitor and a BCL-2 inhibitor.

The FDA announced it has approved Adzynma as prophylactic or on-demand enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura.

The FDA approved Adzynma, the first genetically engineered protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura, a rare and life-threatening blood clotting disorder.