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The supplemental Biologics License Application for the gastric/GEJ cancer indication is supported by data from the double-blind, placebo-controlled MATTERHORN trial.
Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...
We recently compiled a list of 11 Best Future Stocks to Buy Now. Denali Therapeutics Inc. stands sixth on our list among the ...
Based on positive Phase II TRANSCEND FL data showing a 95.5% overall response rate, the FDA has accepted Bristol Myers Squibb’s sBLA for Breyanzi in relapsed or refractory MZL with a PDUFA date set ...
The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...
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.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab as an add-on maintenance treatment for adolescents aged ...
Johnson & Johnson (NYSE:JNJ) announced on Thursday that the U.S. FDA granted priority review for its new drug application aimed at getting marketing approval for TAR-200, a drug-releasing system for ...
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.
Sarepta Therapeutics Inc. SRPT said Wednesday it has completed the sale of its Rare Pediatric Disease Priority Review Voucher for $102 million and will use the proceeds for R&D. Sarepta was ...
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