(Reuters) -British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for ...

Investing.com -- GSK (NYSE: GSK) (LON: GSK) said on Monday that the U.S. Food and Drug Administration has accepted its ...

British drugmaker GSK said on Monday its supplemental new drug application for antibiotic drug gepotidacin has been accepted for priority review by the U.S. Food and Drug Administration for the oral ...

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.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for pembrolizumab in combination with enfortumab vedotin-ejfv for the ...

Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher.

Kyowa Hakko Kirin and Ultragenyx Pharmaceutical recently sold a priority review voucher for $80.6 million to an undisclosed buyer. That’s half the average value that nine previous vouchers sold for.