Page 60 - Priority Review News Today

SKYCLARYS® Approved by FDA in the U.S. Approximately 500 Patient Start Forms Received for SKYCLARYS Marketing Authorization Application for Omaveloxolone in Europe Under Review Announced... | May 10, 2023

Received GSK royalties of $60.3 million, net product revenues of $11.5 million and license revenue of $8.0 million in the first quarter of 2023 Repurchased $40.3 million of common stock and paid... | May 9, 2023

-- First and only approved therapy in Canada that targets genetic impairment in the MC4R pathway - a root cause of early-onset, severe obesity in these patients – -- Approval granted following... | May 8, 2023

-Initiated clinical trials for next generation CAR T candidates, CTX112™ targeting CD19+ B-cell malignancies and CTX131™, targeting CD70+ solid tumors- -Enrollment... | May 8, 2023

-Regulatory submissions complete for exagamglogene autotemcel , formerly known as CTX001™, in the U.S. for transfusion-dependent beta thalassemia and severe sickle cell disease - -EU and U.K.... | May 8, 2023

Patients needing a fecal microbiota transplant for recurrent Clostridioides difficile (C. diff) infections now have the option of ...

Results from a multinational trial of trifluridine/tipracil, known as Lonsurf, with or without bevacizumab in refractory metastatic colorectal cancer (mCRC) have resulted in statistically significantly and clinically meaningful improvements.

The U.S. Food and Drug Administration (FDA) approved the first-ever respiratory syncytial virus (RSV) vaccine for adults aged ...

– NDA for Nirogacestat in Adults with Desmoid Tumors Accepted by the FDA and Granted Priority Review; PDUFA Action Date Set for August 27, 2023 – – Phase 3 DeFi Trial Evaluating... | May 3, 2023

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the...