FDA prioritizes review of liso-cel, a groundbreaking CAR T-cell therapy for relapsed marginal zone lymphoma, promising ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower drug costs. Could it work?

References FDA grants Priority Review to SpringWorks Therapeutics’ New Drug Application for mirdametinib for the treatment of adults and children with NF1-PN. News release. SpringWorks.

2024 Priority Gold Review: Comprehensive analysis of customer reviews, complaints, and reputation highlights company performance. SHERMAN OAKS, CALIFORNIA, UNITED STATES, August 17, 2024 ...

For " priority reviews, " a designation available for drugs offering significant improvements in safety or effectiveness for serious conditions, the performance goal is 6 months.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for odevixibat, an ileal bile acid transporter inhibitor, for the treatment of ...

AstraZeneca (NASDAQ:AZN) and partner Daiichi Sanyko (OTCPK:DSKYF) (OTCPK:DSNKY) said the FDA has accepted their application with priority review for expanded approval of Enhertu for the treatment ...

The FDA granted the priority review based on findings from the phase 3 KEYNOTE-A18 clinical trial (also known in Europe as ENGOT-cx11/GOG-3047) that showed that Keytruda plus concurrent ...

By granting priority review, the FDA commits to making a decision within six months. Gleevec was approved more than a year ago for treating a type of leukemia when the disease is in its later stages.

Priority review is granted to medicines that meet all of the following requirements. In addition, medicines designated as orphan drugs and pioneering medicines will be given priority for review.

Japanese drugmaker Eisai Co Ltd and U.S. biotech firm Biogen Inc said in a joint statement that the Japanese Ministry of Health, Labour and Welfare has granted priority review status to their ...