9 August 2022 - PDUFA date extended to 28 February 2023. ...
1 August 2022 - Submission has been granted priority review and given a target regulatory decision date of 30 November 2022. ...
26 July 2022 - Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as ...
14 July 2022 - Due to COVID travel restrictions, inspections could not be completed during review period. ...
20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...
13 June 2022 - Following additional data submission to FDA demonstrating ORR superiority over ibrutinib as determined by IRC, PDUFA goal ...
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
3 June 2022 - New PDUFA goal date scheduled for 29 September 2022 to allow time to review additional data ...
31 May 2022 - New PDUFA goal date of 28 December 2022. ...
21 May 2022 - Innovation is the lifeblood that has made America the most economically successful nation in the modern era. ...
10 May 2022 - Amicus Therapeutics today announced that the U.S. FDA has extended the review period by 90 days ...
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
1 April 2022 - - Merck today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug ...