Page 26 - Priority Review News Today

Full analysis of multinational pivotal study results of golidocitinib in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) (JACKPOT8 PART B)...

US Food and Drug Administration has granted Priority Review for New Drug Application for elafibranor in PBC, and European Medicine Agency has also validated the Marketing Authorization Application ...

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene...

The FDA approves revolutionary cell-based gene therapies Casgevy and Lyfgenia for sickle cell disease, marking a significant advancement in the treatment of this devastating blood disorder.

Severe vaso-occlusive events were eliminated for 94% of evaluable patients and all VOEs were eliminated for 88% of evaluable patients between 6 and 18 months post-infusion LYFGENIA is the most...

December 8 the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy. 

On Friday, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.

The FDA approved the first cell-based gene therapies, Casgevy and Lyfgenia, for the treatment of sickle cell disease in patients 12 years and older. One of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology.

The FDA has accepted for Priority Review the NDA for elafibranor for the second-line treatment of primary biliary cholangitis.

The FDA has granted Priority Review to the sBLA for Keytruda plus Padcev for first-line treatment of locally advanced or metastatic urothelial cancer.