17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April ...
3 October 2022 - Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, the FDA is creating the Split ...
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
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 ...
18 July 2022 - Australia could become one of the first countries in the world to administer an omicron-specific vaccine, ...
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 ...