1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review ...
14 September 2021 - Calliditas Therapeutics today announced that the U.S. FDA has extended the PDUFA goal date for its ...
23 August 2021 - Axsome Therapeutics today announced that the U.S. FDA informed the Company in a teleconference on August 20, ...
3 August 2021 - Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New ...
2 August 2021 - The agency will now ‘sprint’ to grant full vaccine approval. ...
29 July 2021 - Lawmakers pressed a top FDA official Thursday for answers on why the agency has balked at approving ...
29 July 2021 - The US FDA insists it is working as quickly as possible to review applications for full ...
27 July 2021 - Some say full approval could sway hesitant Americans to get the vaccine. ...
21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the ...
16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...
24 June 2021 - Assigned GDUFA date of 15 December 2021, and expects commercial launch prior to year-end. ...
26 June 2021 - New PDUFA action date for Brixadi set for 15 December 2021. ...